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Olympus A0391Recalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF-cable, monopolar, 4 m, UES-10/20 and Valleylab (old) HF-unit to resectoscope · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04042761001632), received between Jun 3, 2022 and Jun 3, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Noise, Audible1
  • Sparking1

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.

  • MalfunctionJun 3, 2022Break; Sparking; Noise, Audible; Break; Sparking; Noise, Audible

    OLYMPUS RECEIVED A USER FACILITY MEDWATCH REPORT WITH AN EVENT DESCRIPTION OF " SHORTLY AFTER THE PROCEDURE IS STARTED, A LOUD POP IS HEARD AND IMMEDIATELY REALIZED THAT MONOPOLAR CORD SPARKED AND BROKEN OFF WHERE IT ATTACHES TO ESU (ELECTROSURGICAL UNIT) MACHINE". TRANSURETHRAL INCISION OF PROSTATE WAS THE INTENDED PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14597438 ↗

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Sources and updates

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