If a scope or component physically disintegrated inside you during a procedure and you required emergency surgery to remove the fragments, you may have a product liability claim against Olympus Corporation — the device manufacturer. This is a separate case theory from scope infection claims. The injury is the emergency surgery itself, documented in your surgical record. No 30-day infection window is required. Marin & Murphy Law Firm is currently investigating device disintegration claims nationwide.
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A few quick questions about your scope procedure, the infection you were diagnosed with, and whether you were hospitalized. This is the initial intake screening, not a full case review. Most people finish in about two minutes.
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What Is a Scope Fragmentation or Device Disintegration Claim?
A scope fragmentation or device disintegration claim arises when an endoscope — or a component of the scope — physically breaks apart inside a patient's body during a medical procedure. Pieces of the device detach, remain in the body, and require an emergency surgical intervention to retrieve them. The injury is the emergency surgery itself, not a subsequent infection that develops days later. This is a products liability claim against Olympus Corporation — the manufacturer of the device.
The causation chain is short and direct: the device was inserted intact, it broke apart inside the patient, and the patient required emergency surgery to remove the fragments. The surgical record documents every step. There is no need to establish a transmission mechanism, identify a specific pathogen, or demonstrate that an infection developed within 30 days. The legal theory is manufacturing defect and/or design defect. A medical device that physically disintegrates during normal use is defective.
Olympus manufactured the device. Olympus had quality control obligations. When a scope or scope component fragments inside a patient and forces an emergency surgical intervention, the device manufacturer is the responsible party — not the hospital or the physician who performed the procedure. This case theory was confirmed for intake by our co-counsel partners as of April 6, 2026. Zero competitor content addresses this specific theory in the Olympus litigation context as of the sprint launch date — making this one of the highest-priority new content positions in the cluster.
Section B of our confirmed intake criteria states: "If the scope or any component broke apart during your procedure and required emergency surgery to remove fragments, this may represent a separate product liability claim — contact us to discuss." Unlike infection claims, device disintegration cases do not require: a confirmed infection diagnosis; inpatient hospitalization for infection; or IV antibiotic treatment.
The qualifying injury is the emergency surgery required to retrieve the scope fragments. If that surgery is documented in your surgical record, you may have a claim.
Which Olympus Devices Have Been Linked to Fragmentation?
Multiple Olympus devices and device components have been the subject of FDA enforcement actions specifically related to physical fragmentation, component detachment, and device failure:
MAJ-891 Forceps/Irrigation Plug (FDA Class I Recall Z-0905-2025, December 18, 2024)
The FDA classified this recall as Class I — the most serious designation, reserved for devices where there is a reasonable probability of serious adverse health consequences or death. 30,140 units were distributed in U.S. commerce. The manufacturer's stated reason: potential for inadvertent retention of biomaterial when reprocessing is not performed as instructed. The recall language states the device "can result in infection, urinary tract infection, or sepsis and, in some cases, could result in death." 120+ reported injuries and 1 confirmed death are associated with this device in MAUDE adverse event reports.
MAJ-2315 Distal End Cover (FDA Warning Letter MARCS-CMS 654013, March 2023)
The FDA issued a Warning Letter to Olympus after discovering that the MAJ-2315 distal end covers were cracking and detaching from the scope tip — and that Olympus had failed to investigate this known defect for two years. A distal end cover that cracks and detaches during a procedure can leave fragments inside the patient's gastrointestinal tract, airway, or biliary system. The failure to investigate a known component defect for two years is central to the negligence theory.
ViziShot 2 FLEX 19G Endoscopic Ultrasound Needle (FDA Class I Recall, September 2025)
This Olympus accessory was subject to a Class I Recall for component ejection risk. One confirmed death is linked to pre-May 12, 2025 manufactured units. Component ejection — a piece of the needle breaking off and being propelled during use — is a direct fragmentation scenario.
October 2025 Urgent Field Safety Notice (TJF-Q190V, TJF-Q290V, TJF-Q170V)
In October 2025, Olympus admitted that prior inspection protocols for its current-generation duodenoscopes were insufficient — and that damage to scope components was occurring at a level that could not be detected by the naked eye. The admission that 10X magnification tools were required to identify component damage that was previously going undetected supports a broader finding that Olympus devices were physically degrading in ways Olympus knew about and failed to disclose.
How Is a Device Disintegration Claim Different From an Infection Claim?
These are two legally distinct case theories that happen to arise from the same manufacturer's product line. Understanding the difference matters because the qualifying criteria, the evidence required, and the timeline of harm are fundamentally different. An infection claim requires: a scope procedure on or after January 1, 2015; a confirmed infection diagnosis within 30 days; inpatient hospitalization; IV antibiotic treatment; and the absence of specific comorbidities at the time of the procedure.
The causation chain in an infection case goes from the contaminated scope to the patient, with the harm (infection) developing days after the procedure. A device disintegration claim requires none of those elements. The injury is immediate and self-documenting. The scope goes in intact. The scope — or a component of it — breaks apart. The surgical record documents the emergency intervention to retrieve the fragments.
The harm is the emergency surgery itself: anesthesia risks, surgical complications, extended hospitalization, and permanent injury if the emergency intervention causes lasting damage. If a patient died because of complications from the emergency surgery, the claim includes wrongful death. Both types of claims are product liability claims against Olympus Corporation under the same co-counsel agreement. Both can be investigated simultaneously if a patient experienced both a device disintegration event and a subsequent infection.
Contact us to discuss the specific facts of your situation — the intake criteria and causation analysis differ by claim type.
What Injuries and Damages May Support a Device Disintegration Claim?
The qualifying injury in a device disintegration case is emergency surgery required to retrieve scope fragments. The damages that may be available in such a claim include:
- Emergency surgery costs, including anesthesia, surgeon fees, and facility charges
- Extended hospitalization following the emergency intervention
- Complications arising from the emergency surgery itself, including infection, bleeding, or organ injury caused by the surgical intervention
- Permanent injury resulting from the emergency surgery — including damage to structures that were not affected by the original procedure
- Pain and suffering associated with the emergency surgical event
- Lost wages and loss of earning capacity if the emergency surgery and its complications affect the patient's ability to work
- Wrongful death damages if the patient died as a result of complications from the emergency surgery to retrieve scope fragments
This is NOT an infection claim. The standard infection intake criteria — IV antibiotic treatment, inpatient hospitalization for infection — do NOT apply to device disintegration cases. Each device disintegration case is evaluated on its own facts based on the documented emergency surgical intervention.
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What Should I Do If the Scope Broke During My Procedure?
If you or a family member experienced a scope or scope component breaking apart during an endoscopic procedure — and emergency surgery was required to retrieve the fragments — take the following steps immediately:
- Request all surgical records from the emergency intervention. The surgical report documenting the fragment retrieval is the most critical piece of evidence in a device disintegration case. It should identify: that fragments were present, what was retrieved, the scope model and serial number if recorded, and the surgical interventions performed.
- Request the original procedure record for the endoscopy that preceded the emergency surgery. Ask specifically for the device model and serial number of the scope used. Olympus device model numbers include: TJF (duodenoscopes), BF (bronchoscopes), CF (colonoscopes), GIF (gastroscopes), MAJ (accessories including the recalled MAJ-891 and MAJ-2315).
- Preserve any documentation from the hospital regarding the device failure, including incident reports, device quarantine records, or communications from the hospital about what happened during your procedure.
- If you received any communication from the hospital, device manufacturer, or regulatory authority about the device used in your procedure — including recall notices or safety alerts — preserve those documents. Hospitals sometimes notify patients directly when a patient safety event related to a device is identified.
- Contact a device disintegration attorney before your statute of limitations expires. Filing deadlines vary by state and run from the date of the emergency surgery or the date you discovered the connection to a defective device. Do not assume your deadline has passed without speaking to an attorney.
Marin & Murphy Law Firm is investigating Olympus scope and device disintegration claims for patients nationwide. Contact us at (888) 348-2735. The consultation is free and creates no obligation.
You May Qualify If:
- A scope physically broke, fragmented, or disintegrated during your procedure
- Emergency intervention was required to locate and remove scope fragments
- Your procedure involved one of the recalled or flagged Olympus devices: MAJ-891 (FDA Recall Z-0905-2025), ViziShot 2 FLEX 19G, or MAJ-2315
- You suffered physical injury, additional surgery, or complications as a result of the fragmentation
- Your procedure occurred at any U.S. medical facility
Note: Unlike infection-based claims, scope disintegration claims do not require a minimum hospital stay or antibiotic treatment. If a scope broke during your procedure and you were harmed, contact us to discuss your options. The MAJ-891 Class I recall — covering more than 30,000 Olympus forceps units — represents a related device failure claim separate from scope contamination. Scope fragmentation events most commonly occur during ERCP procedures, where the elevator mechanism is subject to the highest mechanical stress.
The manufacturer’s pattern of reporting failures — documented on the Olympus criminal history page — included failure to report scope component failures to the FDA. Scope fragment retention creates an ongoing infection risk — patients who later developed bacteremia or systemic illness should also review the sepsis after endoscopy page, which covers how retained debris can trigger life-threatening bloodstream infections.
A retained scope fragment also creates an ongoing pathway for antibiotic-resistant contamination — patients who developed CRE or similar infections should review the superbug infection after endoscopy page. Scope fragment cases have also coincided with carbapenem-resistant bacterial transmission — the CRE infection lawsuit page covers how CRE spreads through contaminated endoscopes and the resulting claims. The scope deterioration and disintegration issues at the heart of these claims were known to FDA regulators — the FDA warning letters to Olympus page covers the formal enforcement actions that document the agency’s awareness of device integrity failures.
Free Confidential Evaluation — No Fee Unless There Is a Recovery
Contact Marin & Murphy today for a free case evaluation.
Frequently Asked Questions: Scope Broke During Procedure Lawsuit
Can I sue if the scope broke apart during my procedure?
You may be able to file a product liability lawsuit against Olympus Corporation if a scope or scope component physically broke apart inside you during a procedure and you required emergency surgery to remove the fragments. This is a manufacturing defect or design defect claim against the device manufacturer — not a malpractice claim against your doctor. The injury is the emergency surgery itself, documented in your surgical record.
Contact Marin & Murphy for a free evaluation of your specific situation.
What does it mean when a scope or accessory fragments during a procedure?
Scope fragmentation — also called device disintegration — occurs when the scope itself, or an accessory component attached to it, physically breaks apart during the procedure. Pieces of the device separate and remain inside the patient's body. Because these fragments cannot be left in place, emergency surgery is required to retrieve them. The fragmentary failure of a medical device that is inserted into the human body represents a serious product defect. Multiple Olympus devices and components have been subject to FDA enforcement actions specifically for fragmentation and component detachment risks.
Do I need to have developed an infection to file a device disintegration claim?
No. A device disintegration claim does not require a subsequent infection. The injury is the emergency surgery required to retrieve the scope fragments — not an infection that develops days after the procedure. This is a fundamentally different case theory from scope infection claims, with different qualifying criteria and a different causation chain. If you required emergency surgery because a scope or component broke apart during your procedure, you may have a claim regardless of whether you subsequently developed an infection.
Which Olympus devices have fragmentation or disintegration issues?
Multiple Olympus devices have been subject to FDA enforcement actions for fragmentation or component failure. The MAJ-891 Forceps/Irrigation Plug (Class I Recall Z-0905-2025, December 2024) affected 30,140 units, with 120+ reported injuries and 1 confirmed death. The MAJ-2315 distal end cover was the subject of FDA Warning Letter MARCS-CMS 654013 (March 2023) after Olympus failed to investigate cracking and detaching components for two years.
The ViziShot 2 FLEX 19G biopsy needle (Class I Recall, September 2025) was recalled for component ejection risk with 1 confirmed death. The October 2025 Urgent Field Safety Notice also admitted that component damage was occurring below the threshold of naked-eye detection.
How is a scope fragmentation lawsuit different from a scope infection lawsuit?
A scope infection lawsuit requires a confirmed infection developing within 30 days of a scope procedure, inpatient hospitalization, and IV antibiotic treatment. A scope fragmentation lawsuit requires none of those elements. The qualifying injury is the emergency surgery required to retrieve scope fragments — an event that is immediately documented in the surgical record. The causation chain is shorter and cleaner: the device broke, the patient required emergency surgery, and the manufacturer made the defective device.
Both types of claims are product liability claims against Olympus, but the intake criteria and evidence requirements are distinct.
What evidence do I need for a device disintegration claim?
The two most important pieces of evidence are: (1) the emergency surgical report documenting that scope fragments were retrieved, including the model and serial number of the device if recorded; and (2) the original procedure record for the endoscopy that preceded the emergency intervention. Incident reports, hospital communications about the device failure, and any recall or safety notices you received are also valuable.
Absent a serial number, the model designation (beginning with TJF, BF, CF, GIF, or MAJ) is sufficient to begin an investigation. Contact us before concluding that you lack the necessary documentation.
How long do I have to file a device disintegration lawsuit?
Statutes of limitations for product liability claims vary by state — typically two to four years from the date of the emergency surgery or from the date you discovered the connection to a defective device. Filing deadlines are strictly enforced. Even if you believe your deadline may have passed, contact us before assuming you have no options. Depending on the circumstances of your case and how a potential global resolution is structured, there may still be options worth exploring with an attorney.
Who is responsible if a scope broke during my procedure?
The responsible party in a device disintegration case is Olympus Corporation — the manufacturer of the device. The legal theory is that a scope or scope component that physically disintegrates during normal use is defective as designed or manufactured. Olympus had a duty to ensure its devices could withstand the conditions of normal clinical use. When an Olympus device breaks apart inside a patient and forces an emergency surgical intervention, the manufacturer's liability is the central focus of the claim.
The physician and hospital that performed the original procedure are not typically pursued as defendants in device disintegration cases.
Attorney Advertising. Marin & Murphy Law Firm. Prior results do not guarantee a similar outcome.
Related Olympus scope lawsuit resources
- Olympus duodenoscope infection litigation
- The import ban on Olympus devices
- The UCLA duodenoscope CRE outbreak
- Filing an Olympus scope claim in Pennsylvania
- Filing an Olympus scope claim in Illinois
- Filing an Olympus scope claim in Washington
- Filing an Olympus scope claim in California
- Filing an Olympus scope claim in Connecticut
- Filing an Olympus scope claim in Massachusetts
- Filing an Olympus scope claim in Rhode Island
- Adverse events reported in Rhode Island
- Adverse events reported in South Carolina
- Filing an Olympus scope claim in Georgia
- Filing an Olympus scope claim in Texas
- Filing an Olympus scope claim in Florida
- Endoscope infections reported at Hartford Hospital
- Latest Olympus lawsuit developments
Attorney Advertising. This page is general information, not legal advice, and does not create an attorney-client relationship — that relationship is formed only by a signed written agreement. The attorneys of Marin & Murphy Law Firm are licensed in Rhode Island, South Carolina, Connecticut, and Massachusetts. We evaluate potential claims nationwide; for matters arising in states where our attorneys are not admitted, we associate with or refer to locally licensed co-counsel and do not ourselves practice law in those jurisdictions.
Submitting the contact form or contacting the firm does not create an attorney-client relationship. Representation is offered on a contingent-fee basis: no fee unless there is a recovery, though a client may be responsible for case costs and expenses. The statute of limitations may sharply limit the time to file a claim. Prior results do not guarantee a similar outcome, and no outcome is guaranteed. Responsible attorney: Matthew T.
Marin, Marin & Murphy Law Firm (Rhode Island).
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