Olympus A20977ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Bridge, two way · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761020404), received between Sep 27, 2024 and Dec 10, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Break; Break
THE CUSTOMER REPORTED THERE WAS NO PATIENT INJURY DUE TO THE SURGICAL PROLONGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20898104 ↗MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE CYSTOSCOPE BRIDGE WAS NOT WORKING PROPERLY. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20328548 ↗
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- Olympus A22257COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22207COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22221COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22222COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
- Olympus A22231DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.