BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BIPOLAR CABLE

    MDR report key: 24844186 · Received April 10, 2026

    Report

    Report Number
    9610614-2026-00064
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 10, 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 INVOLVED ERBE ESU AND BIPOLAR CABLE WERE THOROUGHLY INSPECTED AND TESTED AS APPLICABLE. THE EVALUATION WAS AS FOLLOWS: ESU THE GENERATOR WAS FOUND TO BE FUNCTIONING AS INTENDED ON (B)(6) 2026. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE UNIT WAS/IS WITHIN SPECIFICATIONS, AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. NO PROBLEMS WERE FOUND WITH THE ESU THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BIPOLAR CABLE A VISUAL EXAMINATION REVEALED VISIBLE SIGNS OF WEAR AND TEAR WITH INSULATION DAMAGE DIRECTLY BEHIND THE KINK PROTECTION. THE DAMAGE INCLUDES PARTIAL BREAKAGE OF THE CABLE STRANDS. THE CABLE HAD UNDERGONE 102 USE/STERILIZATION 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 CRACK. THIS CAN CAUSE A SHORT CIRCUIT OR VOLTAGE FLASHOVER WHICH CAN LEAD TO SPARKING OR AN ELECTRIC ARC. PER THE CABLE NOTES ON USE (NOU) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE ERBE BIPOLAR CABLE DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE BIPOLAR CABLE WAS USED WITH AN ERBE ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 3, PART NUMBER 10160-000, LOT NUMBER 11467045) AND A RESECTOSCOPE FROM WOLF. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY OR THE ESU SETTINGS EMPLOYED IN THE TURP. PER THE REPORT, AN ARC OCCURRED BETWEEN THE BIPOLAR CABLE AND THE RESECTOSCOPE. THIS RESULTED IN SPARKING AND A "BANG" AT THE RESECTOSCOPE. THE DEVICE WAS REPLACED AND NO PATIENT OR USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906044 ERBE BIPOLAR CABLE BIPOLAR CABLE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male