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Olympus A20915ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Cystoscope sheath, 25Fr. · 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 04042761020275), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

  • Material Twisted/Bent1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 29, 2018Material Twisted/Bent; Material Twisted/Bent

    ONE OF 2. OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, THE SHEATH BENT WHILE INSIDE THE PATIENT, TRAPPING AND BREAKING A STONE CRUSHER. THE PROCEDURE ALSO INVOLVED A SEPARATE OLYMPUS OPTICAL FORCEPS DEVICE. ALL DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7827827 ↗

Other Endoscope, Ac-Powered And Accessories devices

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