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Olympus A00012ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF-cable, monopolar, 4 m, UES-30, Erbe Intl. and Valleylab (new) HF-unit to OES Pro resectoscope · 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 04042761029445), received between Apr 13, 2023 and Apr 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Fire1

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.

  • MalfunctionApr 13, 2023Break; Fire; Break; Fire

    IT WAS REPORTED THE USER WAS PERFORMING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE AND HEARD A LOUD SNAP. THE SNAP WAS THE HF CABLE - A00012A BREAKING APART CLOSE TO WHERE IT WAS CONNECTED TO THE GENERATOR. A SMALL FIRE CREATED ON THE CABLE WHERE IT HAD COME APART WAS OBSERVED. THE PROCEDURE WAS COMPLETED. THE PROBLEM DID NOT HAVE AN IMPACT TO THE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16729684 ↗

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