What FDA Adverse Event Reports Reveal About Olympus Scope Infections — A MAUDE Database Analysis

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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.

What Is the FDA MAUDE Database?

The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a publicly accessible repository of adverse event reports submitted to the FDA by medical device manufacturers, importers, and healthcare facilities. Federal law requires that user facilities — including hospitals and ambulatory surgical centers — report device-related patient deaths to the FDA and the manufacturer, and report device-related serious injuries to the manufacturer.

Manufacturers must then report these events to the FDA. For Olympus scope litigation, the MAUDE database is a critical evidentiary resource. Reports document contamination events, CRE and MDRO infections, patient deaths, and device malfunctions linked to Olympus TJF-Q180V, TJF-160VR, and related duodenoscope models.

How to Read MAUDE National Figures

The 248 total reports and 30 deaths reflected in MAUDE represent only events that were actually reported. MAUDE reporting is voluntary for many events and subject to significant underreporting. Public health researchers and FDA internal analyses have found that MAUDE captures only a fraction of actual adverse events linked to reusable medical devices. The 213 reports since January 1, 2015 are particularly significant because that period corresponds to the FDA’s 2015 Safety Communication warning about duodenoscope contamination risk and subsequent enforcement actions.

Reports filed after 2015 reflect a period when the risk was publicly known.

State-Level MAUDE Data

The openFDA API allows state-level queries using the reporter_state_code field. However, this field is frequently left blank by reporting facilities, making state-level counts a known undercount of actual in-state adverse events.

• South Carolina MAUDE adverse event analysis — 11 SC-coded reports, all malfunctions
• Rhode Island MAUDE adverse event analysis — 0 RI-coded reports (see data limitation note)

How Marin & Murphy Uses National MAUDE Data

Marin & Murphy analyzes national MAUDE data as part of its Olympus scope litigation intake process. The firm cross-references MAUDE reports against facility-specific device records, lot numbers, and procedure dates to identify events that may be relevant to a client’s claim. If you underwent a scope procedure at a hospital or surgical center and subsequently developed an infection, our team will analyze available MAUDE reports from that facility as part of your case evaluation.

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.

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).