BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BIPOLAR CABLE; TUR/TCR; STORZ

    MDR report key: 24399543 · Received February 20, 2026

    Report

    Report Number
    9610614-2026-00034
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    September 16, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPOLAR CABLE WAS RETURNED AND EVALUATED. EXAMINATION OF THE CABLE "REVEALED THAT A SMALL TEAR HAD FORMED IN THE INSULATION IN FRONT OF THE STRAIN RELIEF OF THE ANGLED CABLE CONNECTOR. THE CABLE STRANDS ARE ALSO BROKEN AT THIS POINT." THE EVALUATION ALSO NOTED SIGNS OF TYPICAL WEAR WERE VISIBLE. IT WAS DETERMINED THE CABLE WAS REPROCESSED A TOTAL OF 59 CYCLES. BASED UPON THE INSPECTION OF THE CABLE, IT APPEARS THAT THE ACCESSORY WAS SUBJECTED TO FREQUENT AND INTENSE BENDING AND TENSILE STRESSES. THESE STRESSES CAUSED THE COPPER STRAND (WIRING) INSIDE THE CABLE TO BREAK AND THE INSULATION TO TEAR. AS A RESULT, AN "ELECTRIC SENSATION" WAS EXPERIENCED BY THE USER. PER THE CABLE NOTES ON USE (NOU) IT EXPRESSLY STATES THAT THE CABLE SHOULD BE INSPECTED BEFORE USE AND NO LONGER BE USED IF IT IS DAMAGED. ALSO, IT IS RECOMMENDED IN THE NOU TO CHECK THE ELECTRICAL CONDUCTIVITY BEFORE EACH USE. FINALLY, NO ANOMALIES WERE FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT OF THE CABLE. ERBE USA IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE ERBE BIPOLAR CABLE DURING A HYSTEROSCOPY. INFORMATION REGARDING THE ELECTROSURGICAL UNIT (ESU) USED, AND SETTINGS EMPLOYED WERE NOT CONVEYED TO ERBE. IT WAS NOTED THAT A RESECTOSCOPE WAS USED. HOWEVER, NO DETAILS WERE PROVIDED REGARDING ANY OTHER EQUIPMENT OR ACCESSORY INVOLVED IN THE PROCEDURE. PER THE ACCOUNT, IT WAS REPORTED THAT THE "USER EXPERIENCED AN ELECTRICAL SENSATION OR ELECTRIC SHOCK (EXACT LOCATION UNCLEAR)." NO INFORMATION WAS PROVIDED IN REGARD TO ANY LASTING EFFECT OR IMPACT OF THE SHOCK TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467294 ERBE BIPOLAR CABLE; TUR/TCR; STORZ BIPOLAR CABLE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female