BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIO® TWO-PEDAL FOOTSWITCH

    MDR report key: 24659775 · Received March 23, 2026

    Report

    Report Number
    9610614-2026-00058
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ERBE ESU AND TWO-PEDAL FOOTSWITCH WERE THOROUGHLY INSPECTED/TESTED. THE EVALUATION WAS AS FOLLOWS: ESU 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. TWO-PEDAL FOOTSWITCH THE FOOTSWITCH BEING 15 YEARS OLD SHOWED NORMAL SIGNS OF WEAR. INSPECTION/TESTING REVEALED THAT "THE SWITCHING ELEMENT NO LONGER RELEASES RELIABLY UNDER UNFAVORABLE ATMOSPHERIC CONDITIONS, WHICH CAN LEAD TO PERMANENT ACTIVATION." THE FAILURE MODE COULD BE REPLICATED AT LOW TEMPERATURES. RELIABLE FUNCTION WAS CONFIRMED IN THE LABORATORY AFTER SPECIFIED ACCLIMATIZATION TIME AT TEMPERATURES ABOVE 10C. AT TEMPERATURES BELOW 5C, SPORADIC STICKING OF THE SWITCHING ELEMENT OCCURRED. THE SPRING RETURN MECHANISM FUNCTIONED AS INTENDED. NO MATERIAL OR MANUFACTURING DEFECT IS APPARENT. NO OTHER COMPARABLE EVENTS WITH THIS BATCH OF FOOTSWITCHES WERE RECORDED IN THE COMPLAINT DATABASE. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ESU OR FOOTSWITCH. IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OR CAUSES OF THE CONTINUOUS ACTIVATION OF THE COAG FOOTSWITCH PEDAL. PER THE FOOTSWITCH NOTES ON USE (NOU), A FUNCTIONAL CHECK SHOULD BE PERFORMED PRIOR TO EACH USE. THE NOU ALSO STATES THAT THE PRODUCT MUST BE ACCLIMATED AT ROOM TEMPERATURE FOR APPROXIMATELY 3 HOURS PRIOR TO USE IF THE PRODUCT WAS STORED OR TRANSPORTED BELOW 10C.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VIO® TWO-PEDAL FOOTSWITCH WAS INVOLVED IN A PATIENT INCIDENT DURING A TRANSURETHRAL RESECTION OF THE BLADDER (TURB). THE FOOTSWITCH WAS USED WITH AN ERBE ELECTROSURGICAL UNIT [ESU/GENERATOR, MODEL VIO ® 200 S, PART NUMBER (P/N) 10140-400, SERIAL NUMBER (S/N) (B)(6]. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY, OR THE ESU SETTINGS EMPLOYED DURING THE PROCEDURE. PER THE COMPLAINANT THERE WAS UNINTENDED CONTINUOUS ACTIVATION OF THE FOOTSWITCH DURING THE PROCEDURE. THE REPORT STATED, "COAG MODE REMAINED ACTIVE EVEN AFTER THE FOOTSWITCH WAS RELEASED." THE USE OF THE UNIT WAS DISCONTINUED AND A CYSTOGRAM WAS PERFORMED TO RULE OUT PERFORATION. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED OR EXTENDED HOSPITAL STAY WAS REPORTED. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726314 VIO® TWO-PEDAL FOOTSWITCH FOOTSWITCH GEI ERBE ELEKTROMEDIZIN GMBH WO161477

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other