BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22540871 · Received July 18, 2025

    Report

    Report Number
    9610614-2025-00042
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    May 31, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPOLAR CABLES WERE RETURNED AND EVALUATED. AS REPORTED, BOTH CABLES SHOWED THERMAL DAMAGE IN THE FORM OF VOLTAGE BREAKDOWN ON THE INSTRUMENT-SIDE CONNECTOR. EACH OF THE BIPOLAR CABLES HAD BEEN STERILIZED AND USED FIVE (5) TIMES. ACCORDING TO THE PRODUCTION DOCUMENTS (I.E., THE PRODUCTION ORDER, TEST CERTIFICATE, AND/OR PRODUCT RELEASE OF THE DEVICES), THE CABLES WERE MANUFACTURED AND TESTED IN ACCORDANCE WITH THE SPECIFICATIONS, INCLUDING VOLTAGE RESISTANCE AND ELECTRICAL CONTINUITY. IT CAN THEREFORE BE ASSUMED THAT THEY WERE INTACT AND FUNCTIONING PROPERLY WHEN THEY WERE DELIVERED TO THE ACCOUNT. CHARRING AND MELTING MARKS USUALLY OCCUR BECAUSE OF HEATING DUE TO VARIOUS CAUSES. WE CONCLUDE THAT THE CABLE BREAK ON THE INSTRUMENT SIDE MAY HAVE BEEN CAUSED MECHANICALLY BY PRESSURE, TENSILE STRESS, AND KINKING DURING INTENSIVE USE AND THE ASSOCIATED WEAR AND TEAR. THE SHORT CIRCUIT OR VOLTAGE FLASHOVER CAN LEAD TO SPARKING/ARC FORMATION. THE VOLTAGE FLASHOVER MAY ALSO HAVE OCCURRED IN CONNECTION WITH RESIDUAL MOISTURE IN THE CONNECTOR (E.G., DUE TO INSUFFICIENT DRYING TIME AFTER REPROCESSING). PER THE CABLE NOTES ON USE (NOU) THERE MUST BE SUFFICIENT DRYING OF THE PRODUCT AFTER REPROCESSING. ALSO, THE NOU EXPRESSLY STATES THAT THE CABLE SHOULD BE INSPECTED BEFORE USE AND NO LONGER BE USED IF IT WAS DAMAGED. IN THIS CASE, IT IS ALSO CONCEIVABLE THAT A DAMAGED RESECTOSCOPE WAS USED OR THAT THERE WAS RESIDUAL MOISTURE IN THE RESECTOSCOPE CONNECTION. THE RESECTOSCOPE WOULD HAVE TO BE THOROUGHLY CHECKED BY ITS MANUFACTURER. OVERALL, IT IS THE RESPONSIBILITY OF THE USER TO HANDLE THE CABLES WITH CARE AND TO CHECK THEM PRIOR TO USE. NO TRENDS HAVE BEEN IDENTIFIED AND 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 TWO (2) ERBE BIPOLAR CABLES DURING A 2 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 WAS NOT CONVEYED TO ERBE. IT WAS REPORTED THAT THERE WAS A VOLTAGE BREAKDOWN ON THE INSTRUMENT-SIDE CONNECTOR OF THE 2 BIPOLAR CABLES DURING THE PROCEDURES. THERE WAS NO REPORT OF ANY PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426683 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