BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CABLE; TUR/TCR; STORZ; MF PLUG, L 4M

    MDR report key: 23726310 · Received December 5, 2025

    Report

    Report Number
    9610614-2025-00079
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPOLAR CABLE WAS RETURNED AND EVALUATED. A VISUAL EXAMINATION REVEALED THAT THE CABLE'S ANGLED CONNECTOR INSIDE THE KINK PROTECTION HAD BROKEN. THE INSULATION OF THE CABLE AT THE LOCATION OF THE BREAK WAS BLACKENED BY SOOT BUT SHOWS NO SIGNS OF DIELECTRIC BREAKDOWN. THE INTERNAL COOPER WIRING WAS ALSO BLACK BUT SHOWS NO SIGNS OF CORROSION. 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. ONCE THE INTERNAL COPPER WIRING BROKE, THE CABLE COULD NO LONGER WITHSTAND THE MECHANICAL STRESSES. AS A RESULT, THE CABLE BROKE AT THE DAMAGED AREA. 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. NO TRENDS HAVE BEEN IDENTIFIED. ERBE USA, INC. IS NOW 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 TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). INFORMATION REGARDING THE ELECTROSURGICAL UNIT (ESU) USED, AND ANY OTHER ACCESSORIES INVOLVED WAS NOT PROVIDED. ALSO, THE ESU SETTINGS EMPLOYED WERE NOT CONVEYED TO ERBE. HOWEVER, IT WAS REPORTED THAT THE INSTRUMENT-SIDE CONNECTOR OF THE CABLE BROKE DURING THE PROCEDURE AND CAUSED SMOKE TO DEVELOP. THERE WAS NO REPORT OF ANY USER OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844116 BIPOLAR CABLE; TUR/TCR; STORZ; MF PLUG, L 4M BIPLAR CABLE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male