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Olympus A0357Recalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF cable, monopolar, 3.5 m, Martin and Berchtold HF-unit to HiQ, HiQ+ · 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 04042761001540), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 malfunction.

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

  • Arcing1

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.

  • MalfunctionMar 22, 2023Arcing; Arcing

    THE THIRD PARTY DISTRIBUTOR REPORTED TO OLYMPUS; THE CUSTOMER MONOPOLAR HIGH FREQUENCY CABLE WAS RETURNED TO THE DISTRIBUTOR FOR REPAIR FOR A REPORTED ¿CONTACT FAILURE¿ WHICH WAS FOUND DURING PREPARATION FOR USE. THE DISTRIBUTOR¿S INSPECTION FOUND THE CABLE WAS BURNT AND BROKEN WHICH IS LIKELY ATTRIBUTED TO INTERNAL WIRES BEING SEPARATED AND CAUSED ARCING TO OCCUR. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BURNT AND BROKEN CABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16594688 ↗

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