Received a Letter From Your Hospital About a Recent Scope Procedure? Here Is What It Means and What to Do Next

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Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

If you were told it was “just a complication,” Olympus’s federal guilty plea — and $85 million in penalties — tell a different story. In two minutes, you can know whether your case qualifies.

ACTIVE LITIGATION. 250+ patients · most recent filing: June 2026 · deadlines vary by state — some as short as one year.

Were you hospitalized with an infection within 30 days of an endoscopy or scope procedure?

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Free · confidential · no fee unless there is a recovery · answering doesn’t commit you to anything. Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

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Stefanie A. Murphy & Matthew T. Marin

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You’ll get a straight answer even if it’s “you don’t qualify.” Everything you share is confidential — even if you never hire us. No fee unless there is a recovery; costs are advanced and reimbursed only out of a recovery. If you do qualify, our Olympus scope litigation team requests the medical and hospital records — you don’t chase them.

Qualification depends on what the medical records show — the scope involved, the infection, and the timing. We’ll review them and give you a straight answer either way.

Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Why Did My Hospital Send Me This Letter?

Hospitals send these letters as part of their patient-safety and infection-control responsibilities, and to inform patients who may have been affected by a potential device-related exposure. In plain terms: when a scope manufacturer issues an urgent field safety notice admitting its devices posed a contamination risk, the hospital that used those devices must contact every patient who underwent a procedure with them.

The most significant recent trigger for these letters was the Olympus Urgent Field Safety Notice issued between October 14 and 17, 2025. In that notice, Olympus made a striking admission: the prior reprocessing protocols for its current-generation TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes were insufficient. Olympus disclosed that hospitals were never previously instructed to use 10X magnification tools during visual inspection — tools the company now concedes are necessary to detect damage and contamination that cannot be seen with the naked eye.

That notice was linked to 2 confirmed deaths and 5 serious injuries. An 8-year retrospective study found that by 2022, 94.7% of patient-ready duodenoscopes showed measurable bacterial contamination of any type — and that all manufacturer-recommended interventions failed to meaningfully reduce that rate. (Source: van der Ploeg et al., Gut, March 2024, PMID 38182137.)

It is critical to understand what this letter does not mean. The hospital that sent you this letter is not the defendant in this litigation. Hospital staff followed the reprocessing instructions Olympus provided, and no hospital in any confirmed outbreak was found to have deviated from the manufacturer’s guidelines. The legal theory in pending litigation is directed entirely at Olympus Corporation — the device manufacturer — for failing to provide adequate cleaning protocols and for failing to warn hospitals and patients about contamination risks it had documented internally for years. The hospital complied with what Olympus told it to do.

What Does This Letter Mean for My Legal Rights?

The letter your hospital sent you is more than a routine notification. In the context of a product liability claim against Olympus Corporation, it constitutes the hospital’s documented acknowledgment of a potential device-related patient safety event. It establishes that a safety issue involving a scope was identified at your facility, that you were an affected patient, and that federal regulation required the hospital to notify you. That combination makes the letter relevant evidence in any subsequent legal proceeding. Retain the original document.

The October 2025 Urgent Field Safety Notice carries particular weight as retroactive authority. Because Olympus admitted that prior reprocessing protocols for the TJF-Q190V, TJF-Q290V, and TJF-Q170V were insufficient, that admission applies to every procedure performed before October 2025. If you underwent an endoscopy in 2015, 2018, 2021, or any year before the notice, Olympus’s 2025 admission is directly relevant to whether adequate cleaning instructions were in place at the time of your procedure.

The timeline for filing a legal claim — the statute of limitations — varies significantly by state, making prompt attorney consultation critical. Individual circumstances — including when you first discovered that your infection was connected to the scope procedure and your state’s specific discovery rules — can affect when the limitations clock began to run. Consulting an attorney promptly is the only reliable way to protect your rights.

Peer-reviewed research confirms that contamination could cause a clinical infection even when the hospital followed every protocol correctly. A study at Virginia Mason Medical Center found multidrug-resistant E. coli on 4 of 8 Olympus duodenoscopes tested despite no identified breach in the hospital’s high-level disinfection protocol. (Source: Ross et al., Gastrointestinal Endoscopy, September 2015, PMID 26092616.) The hospital did nothing wrong. The scopes were still contaminated. That is the central legal argument against Olympus.

What Types of Infections Are Linked to Contaminated Olympus Scopes?

The most dangerous infection associated with contaminated Olympus duodenoscopes is carbapenem-resistant Enterobacteriaceae, known as CRE. CRE is a category of bacteria resistant to most available antibiotics, including carbapenems — the drugs typically reserved as a last resort for the most severe infections. CRE bloodstream infections are associated with mortality rates approaching 50 percent, according to the CDC MMWR Vital Signs report published March 5, 2013.

Once CRE enters the bloodstream, physicians have very few remaining treatment options. Patients who develop CRE following a scope procedure face one of the most serious infectious disease outcomes in modern medicine.

Three documented hospital outbreaks illustrate the scale of harm these devices caused. At an Illinois teaching hospital, 39 case patients developed NDM-1 — a form of CRE — in 2013. The statistical association was overwhelming: an odds ratio of 78 (95% CI, 6.0–1008), meaning patients who underwent ERCP at that hospital were 78 times more likely to develop NDM-CRE infection (Epstein et al., 2014). (Source: Epstein et al., JAMA, October 2014, PMID 25291580.) At Ronald Reagan UCLA Medical Center, 17 patients were infected with carbapenem-resistant Klebsiella pneumoniae; 2 patients died and approximately 179 patients were potentially exposed. No deviation from FDA or manufacturer reprocessing recommendations was found.

(Source: Humphries et al., PMID 29579235.) At Virginia Mason Medical Center in Seattle, 32 patients developed multidrug-resistant E. coli infections; 7 died within 31 days and 16 had died overall by March 2015, with MDR E. coli confirmed on 4 of 8 Olympus duodenoscopes despite no identified protocol breach. (Source: Ross et al., PMID 26092616.)

Independent research teams using different methodologies have reached consistent conclusions about contamination risk. Standard high-level disinfection leaves a significant share of patient-ready duodenoscopes contaminated with gastrointestinal bacteria even when staff follow manufacturer instructions exactly. A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5% contamination even after enhanced protocols, with 0.8% high-risk organisms.

And the 8-year a Dutch tertiary-care hospital study found 94.7% of patient-ready scopes showed any-organism contamination by 2022, with all manufacturer-recommended interventions failing to produce a meaningful reduction. (Sources: Larsen et al., 2020, cited in Bomman et al., Clinical Endoscopy, January 2022, PMC8831410; van der Ploeg et al., Gut, 2024, PMID 38182137.)

The safety problem extends beyond contamination risk. The December 2024 Class I FDA Recall of the Olympus MAJ-891 Forceps/Irrigation Plug affected 30,140 units in U.S. commerce and was associated with 120 or more reported injuries and 1 confirmed death. (Source: FDA Recall Z-0905-2025.) The October 2025 Urgent Field Safety Notice was separately linked to 2 additional confirmed deaths and 5 serious injuries.

What Qualifying Injuries May Support a Legal Claim?

To bring a potential product liability claim against Olympus in this litigation, specific clinical criteria must be met. The governing requirement is that any infection — and the resulting hospitalization — must have occurred within 30 days of your scope procedure. Most patients in confirmed outbreak cases developed symptoms within approximately five days of their procedure; the 30-day window is the applicable hard cutoff.

Inpatient hospitalization is required. Patients treated solely on an outpatient basis with oral antibiotics do not currently meet the intake criteria. The infection must have been serious enough to require hospital admission and IV antibiotic treatment during that hospitalization. Both requirements must be present: inpatient admission and IV antibiotics.

Qualifying organisms and conditions include carbapenem-resistant Enterobacteriaceae (CRE), NDM-1 producing organisms, ESBL-producing bacteria, vancomycin-resistant Enterococcus (VRE), methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae, and Pseudomonas aeruginosa. Sepsis following a scope procedure, particularly where intensive care admission was required, may support a claim. Organ failure arising from a post-procedure infection also qualifies.

Wrongful death claims are accepted where a patient died as a result of a scope-associated infection meeting these criteria. Separately, if the scope or any component physically broke apart during your procedure and emergency surgery was required to retrieve fragments, this may represent a distinct product liability theory based on device disintegration — contact us to discuss.

Which Hospitals Have Been Linked to Olympus Scope Contamination?

Virginia Mason Medical Center in Seattle, Washington was the site of a documented Olympus scope outbreak. Between November 2012 and August 2013, 32 patients developed multidrug-resistant E. coli infections during a period when 1,149 ERCP procedures were performed. Seven patients died within 31 days; 16 had died overall by March 2015. Testing confirmed MDR E. coli on 4 of 8 Olympus duodenoscopes despite no identified breach in the hospital’s high-level disinfection protocol. (Source: Ross et al., PMID 26092616.)

Ronald Reagan UCLA Medical Center in Los Angeles confirmed 17 patients infected with carbapenem-resistant Klebsiella pneumoniae, 2 deaths, and approximately 179 patients potentially exposed, according to Humphries et al. (PMID 29579235). A field investigation found no deviations from FDA or manufacturer reprocessing recommendations.

An Illinois teaching hospital was the site of a documented NDM-CRE outbreak traced to a medical device. In 2013, 39 case patients developed NDM-producing E. coli. The odds ratio for duodenoscope exposure at that facility was 78 (95% CI, 6.0–1008) (Epstein et al., 2014). (Source: Epstein et al., JAMA, 2014, PMID 25291580.)

Multiple U.S. hospitals were named in the U.S. Senate HELP Committee report released January 13, 2016. The Senate HELP Committee estimated at least 250 patients worldwide, across all three duodenoscope manufacturers, contracted potentially deadly infections from contaminated duodenoscopes and stated that figure is likely a significant undercount. If you received a letter from any hospital — whether named above or not — contact Marin & Murphy for a free evaluation.

What Is Olympus Corporation’s Regulatory History?

On February 19, 2015, the FDA issued a Safety Communication stating that manufacturer cleaning instructions for ERCP duodenoscopes may be insufficient. The FDA disclosed that between January 2013 and December 2014, it had received 75 Medical Device Reports involving approximately 135 patients — all before any public warning was issued to hospitals or patients. (Source: FDA Safety Communication, February 19, 2015.)

In March 2018, the FDA issued Warning Letter MARCS-CMS 546986 documenting that more than two years after a mandatory postmarket surveillance order had been issued, Olympus had not established a single surveillance site as required.

On December 10, 2018, Olympus Medical Systems Corporation and former senior executive Hisao Yabe pleaded guilty to three counts of distributing misbranded medical devices. Olympus paid an $85 million penalty and admitted to failing to file FDA-required adverse-event reports, including documented patient infections linked to its duodenoscopes. (Source: DOJ press release, December 10, 2018.) For a complete timeline of Olympus’s regulatory history, see the Olympus criminal history page.

In March 2023, the FDA issued Warning Letter MARCS-CMS 654013 finding that Olympus had failed to investigate cracked MAJ-2315 distal end covers for two years. In December 2024, the FDA issued a Class I Recall of the MAJ-891 Forceps/Irrigation Plug, affecting 30,140 U.S. units. On June 24, 2025, the FDA issued Import Alert 89-04, blocking 58 Olympus device models from U.S. entry due to ongoing quality system violations at its Aizu, Japan manufacturing facility.

Between October 14 and 17, 2025, Olympus issued a worldwide Urgent Field Safety Notice admitting prior reprocessing protocols were insufficient — linked to 2 confirmed deaths and 5 serious injuries. In March 2026, Health Canada recalled Olympus MAJ-1443 and MAJ-1444 valve accessories.

The legal argument in this litigation is that Olympus — not the hospital — was responsible for providing safe cleaning instructions. Hospitals reported following the reprocessing instructions Olympus provided at the relevant time. Whether those instructions were adequate is a contested issue in the litigation. Tennessee patients face the shortest deadline in this litigation — see the Tennessee Olympus scope lawsuit page for the 1-year statute of limitations details. Contaminated Olympus scopes have been linked to superbug infection after endoscopy at multiple facilities.

What Should I Do After Receiving a Hospital Exposure Letter?

If you received a hospital exposure letter about a recent scope procedure, take the following steps to protect your legal rights and preserve critical evidence:

1. Do not discard the letter. It is a primary piece of evidence documenting that the hospital identified a potential device-related patient safety event and that you were an affected patient. Keep the original in a safe location.
2. Request medical records. The key records to obtain are: the procedure record showing the device model and serial number; any infection diagnosis records following the procedure; inpatient hospitalization records within 30 days of the procedure; and microbiology culture reports identifying any organism responsible for infection.
3. Do not contact hospital risk management without attorney advice. You are not obligated to provide statements or answer questions from the hospital’s risk management or legal team before consulting your own attorney.
4. Do not sign any release without attorney review. Any document that appears to waive or settle claims related to the procedure should be reviewed by a mass tort attorney before you sign it.
5. Document your symptoms and medical history since the procedure. Write down a chronological timeline of symptoms, hospitalizations, antibiotic treatments, and follow-up care since the scope procedure.
6. Contact a mass tort attorney for a free, confidential consultation. An attorney can evaluate whether your procedure type, infection diagnosis, and hospitalization history match current intake criteria for Olympus scope litigation. Call Marin & Murphy at (888) 348-2735.

Frequently Asked Questions

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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).