Olympus A37011ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · 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 04042761023160), received between Oct 31, 2025 and Oct 31, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
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.
MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD THE ELECTRODE LOOP SNAP. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE MALFUNCTION OCCURRED DURING A THERAPEUTIC TRANS CERVICAL RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439836 ↗
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- Olympus A22205DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall5 reports
- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.