BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE SLIM-LINE ELECTROSURGICAL PENCIL WITH ROCKER SWITCH

    MDR report key: 22769765 · Received August 11, 2025

    Report

    Report Number
    9610614-2025-00050
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K925619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE ESU WAS THOROUGHLY INSPECTED AND TESTED (NOTE: THE ERBE ESU PENCIL WAS DISPOSED OF BY THE CUSTOMER; THERFORE, IT WAS NOT AVAILABLE FOR AN EXAMINATION.). 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. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO PROBLEMS WERE FOUND WITH THE ESU THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE MANY POSSIBLE SCENARIOS INVOLVED WITH REPORTED UNINTENDED ACTIVATION OF THE ESU PENCIL. THE USER SUSPECTED THAT THE FAILURE OF THE PENCIL WAS DUE TO ITS ROCKER SWITCH STICKING. A STICKING SWITCH COULD HAVE BEEN CAUSED BY THE ACCESSORY BEING DAMAGED, OVERUSED/STRESSED, ETC. THE ESU PENCIL'S NOTES ON USE (NOU) STATES THAT THE PRODUCT MUST BE CHECKED FOR EXTERNAL DAMAGE BEFORE USE. ALSO, THE PRODUCT MUST BE PROTECTED FROM ANY FORM OF MECHANICAL DAMAGE (NOTE: NO INFORMATION WAS PROVIDED INVOLVING HOW MANY TIMES THE DEVICE WAS USED, THE NUMBER OF REPROCESSES, ETC.). PER THE NOU, DAMAGED PRODUCT MUST NOT BE USED. HOWEVER, WITHOUT INSPECTING/TESTING THE DEVICE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE(S) OF THE REPORTED ACCESSORY FAILURE. THE REPORT OF THE ELECTROCARDIOGRAPHY MONITOR INTERFERENCE WAS MOST LIKELY CAUSED BY THE APPLICATION OF THE GENERATOR'S HIGH FREQUENCY (HF) CURRENT NEAR THE ECG ELECTRODES AND WAS NOT A RESULT OF A PROBLEM WITH THE ESU [NOTE: THE LEAKAGE CURRENT OF THE UNIT WAS WELL BELOW THE ELECTRICAL STANDARDS AND THE GENERATOR'S USER MANUAL PROVIDES GUIDANCE ON DEALING WITH ELECTROMAGNETIC COMPATIBILITY (EMC).]. 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 THE ERBE ESU PENCIL WAS INVOLVED IN AN INCIDENT DURING THE IMPLANTATION OF A PACEMAKER. THE ESU PENCIL WAS USED WITH AN ERBE ELECTROSURGICAL UNIT (ESU, MODEL VIO 200 D, PART NUMBER 10140-200, AND SERIAL NUMBER (B)(6). NO INFORMATION WAS PROVIDED REGARDING THE ESU'S SETTINGS, OR ANY OTHER ACCESSORY USED DURING THE PROCEDURE. THE USER CONVEYED TO ERBE THAT THE ERBE PENCIL ACTIVATED ON ITS OWN (UNINTENTIONALLY) FOR APPROXIMATELY 30 SECONDS UNTIL THE POWER CORD WAS UNPLUGGED [NOTE: UNRELATED TO THE ACTIVATION ISSUE WITH THE ESU PENCIL, THE USER EXPERIENCED SOME ELECTRICAL INTERFERENCE WITH THEIR ELECTROCARDIOGRAPHY (ECG) MONITOR DURING THE OPERATION.]. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109353 ERBE SLIM-LINE ELECTROSURGICAL PENCIL WITH ROCKER SWITCH ESU PENCIL GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female