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Olympus WA05991ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Instrument tray, for flexible endoscopes of CHF, CYF, ENF, HYF, LF, and URF series · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761062541), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Peeled/Delaminated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 15, 2022Peeled/Delaminated; Peeled/Delaminated

    THE CUSTOMER REPORTED TO OLYMPUS THE DEVICE PRESENTED AN NOISY IMAGE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, IT WAS OBSERVED THAT THE COATING OF THE SERPENTINE TUBE WAS PEELED OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13534318 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.