BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BIPOLAR CABLE

    MDR report key: 25334583 · Received May 29, 2026

    Report

    Report Number
    9610614-2026-00087
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED BIPOLAR CABLE WAS MADE AVAILABLE AND THOROUGHLY INSPECTED. A VISUAL EXAMINATION REVEALED TEAR IN THE INSULATION IMMEDIATELY BEHIND THE KINK PROTECTION OF THE 90° ANGLED INSTRUMENT CONNECTOR. THE AREA BEHIND THE KINK PROTECTION SHOWED VISIBLE CHARRING. THE INNER CONDUCTORS AT THIS PART OF THE CABLE WERE SEVERED AND CHARRED. BASED ON THE CHARRING AND TEAR AT THIS CABLE LOCATION, THE ELECTRICAL ARC MOST LIKELY OCCURRED FROM THIS AREA. THE CABLE SHOWED TYPICAL SIGNS OF WEAR. THE CABLE IS SIX (6) YEARS OLD AND HAS UNDERGONE 76 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 CABLE BREAK WHICH CAN PRODUCE A SHORT CIRCUIT OR VOLTAGE FLASHOVER. THIS CAN LEAD TO SPARKING OR AN ELECTRIC ARC. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE ERBE BIPOLAR CABLE DURING A HYSTERECTOMY. THE BIPOLAR CABLE WAS USED WITH A STORZ RESECTOSCOPE. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY OR THE ESU USED IN THE PROCEDURE. PER THE REPORT, "THE CABLE OF A BIPOLAR RESECTOSCOPE CAUSED AN ELECTRICAL ARC ON THE SURGICAL DRAPE." THIS RESULTED IN THE SURGEON'S GLOVE "MELTING." THERE WAS NO REPORTED PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465414 ERBE BIPOLAR CABLE BIPOLAR CABLE GEI ERBE ELEKTROMEDIZIN GMBH 0819

    Patients

    Seq Age Sex Outcome Treatment
    1