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Olympus A37012ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761023177), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1

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.

  • InjuryJun 2, 2022Material Deformation; Material Deformation

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL URETERAL STENOSIS DILATION PROCEDURE, THE HF ELECTRODE DID NOT COME OUT SUFFICIENTLY FROM THE SHEATH WHEN THE WORKING ELEMENT WAS OPERATED AND THUS NO ELECTRICITY WAS APPLIED. SINCE NO SPARE ELECTRODES HAD BEEN PREPARED THE INTENDED SURGERY HAD TO BE ABORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14573055 ↗

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