BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BIPOLAR CABLE

    MDR report key: 24883697 · Received April 15, 2026

    Report

    Report Number
    9610614-2026-00066
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 15, 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 BIPOLAR CABLE WAS NOT PROVIDED TO ERBE FOR AN EXAMINATION, BUT IT WAS SENT TO SANA'S PARTNER, MEDWORX, FOR REPAIR. HOWEVER, A PHOTOGRAPH OF THE CABLE WAS FURNISHED. IT SHOWED A SMALL HOLE NEAR THE INSTRUMENT CONNECTOR ON THE KINK PROTECTION. THE ESU WAS THOROUGHLY INSPECTED AND TESTED BY ERBE ON 04/01/26. THE GENERATOR WAS FOUND TO BE FUNCTIONING AS INTENDED. 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. BASED UPON THE PROVIDED INFORMATION AND THE EVALUATION WORK, MOST LIKELY, THERE WAS RESIDUAL MOISTURE IN THE CONNECTOR OF THE CABLE. THEN, UPON ACTIVATING THE ESU, AN ARC OCCURRED WHICH RESULTED IN SPARKING THAT DAMAGED THE CABLE'S KINK PROTECTION AND HEATED UP THE ENDOSCOPE. ALSO, DIRECT AND/OR LOW-FREQUENCY CURRENT WAS GENERATED, WHICH LEAD TO THE PATIENT EXPERIENCING NEUROMUSCULAR STIMULATION INCLUDING IRRITATION. ACCORDING TO THE CABLE'S NOTES ON USE (NOU), SUFFICIENT DRYING TIME MUST BE ENSURED AFTER REPROCESSING THE CABLE. HOWEVER, IT CANNOT BE EXCLUDED THAT THE CABLE WAS ALREADY DAMAGED PRIOR TO USE (NOTE: PER THE CABLE'S NOU, USERS ARE REQUIRED TO INSPECT THE CABLE FOR DAMAGE BEFORE USE. IF THERE IS OBVIOUS DAMAGE, THE CABLE MUST NO LONGER BE USED. ERBE 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). THE BIPOLAR CABLE WAS USED WITH AN ERBE ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 3, PART NUMBER 10160-000, SERIAL NUMBER (B)(6), DATE OF MANUFACTURING 04/04/2022) AND A RESECTOSCOPE FROM STORZ. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY OR THE ESU SETTINGS EMPLOYED IN THE TURP. PER THE REPORT, SPARKS WERE OBSERVED AT THE ENDOSCOPE'S CONNECTOR, AND THE ENDOSCOPE BECAME WARM. ALSO, THE CABLE SHORT-CIRCUITED AND THE PATIENT EXPERIENCED NEUROMUSCULAR IRRITATION. THERE WAS NO REPORT OF ANY PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943071 ERBE BIPOLAR CABLE BIPOLAR CABLE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male