BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWO-PEDAL FOOTSWITCH; VIO®3 REMODE; BRACKET; MIDDLE PIECE

    MDR report key: 23533915 · Received November 12, 2025

    Report

    Report Number
    9610614-2025-00072
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOOTSWITCH WAS RETURNED AND INSPECTED/TESTED. DURING AN INITIAL EVALUATION, THE REPORT OF THE FOOTSWTICH'S CUT PEDAL STICKING COULD NOT BE INDUCED/DUPLICATED. BOTH PEDALS OF THE FOOTSWITCH WORKED AS INTENDED WHEN TESTED. HOWEVER, THE SPRING MECHANISM OF THE FOOTSWITCH'S YELLOW (CUT) PEDAL PRODUCED A NOTICEABLE CREAKING SOUND WHEN DEPRESSED. TO FURTHER INVESTIGATE THE REPORTED ISSUE, THE FOOTSWITCH WAS RETURNED TO OUR PARENT COMPANY, ERBE ELEKTROMEDIZIN GMBH (GERMANY), FOR A MORE IN-DEPTH ANALYSIS. IF ANY CONCLUSIVE DETERMINATION IS MADE BY ERBE GERMANY AS TO THE CAUSE(S) OF THE REPORTED ISSUE, THEN A FOLLOW-UP MDR WILL BE FILED. THE ACCOUNT WILL BE MADE AWARE OF THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VIO 3 TWO-PEDAL FOOTSWITCH WAS INVOLVED IN AN INCIDENT DURING A MYOTOMY (NOTE: THE FOOTSWITCH HAD NOT BEEN USED IN MANY PROCEDURES). THE FOOTSWITCH WAS USED WITH AN ERBE ELECTROSURGICAL UNIT [ESU, MODEL VIO 3, PART NUMBER (P/N) 10160-000, AND SERIAL NUMBER (S/N) INFORMATION NOT PROVIDED (NI)], AN ERBE ARGON PLASMA COAGULATOR (APC, MODEL APC 3, P/N 10135-000, AND S/N NI), AN ERBE HYDROSURGICAL UNIT (MODEL ERBEJET 2, P/N 10150-000, AND S/N NI), AND AN ERBE HYBRIDKNIFE (P/N NI AND LOT NUMBER NI). NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED IN THE PROCEDURE. THE ESU SETTINGS WERE ENDOCUT I, EFFECT 3, CUT DURATION 2, CUT INTERVAL 1. TOWARDS THE END OF THE MYOTOMY, THE PHYSICIAN DEPRESSED THE CUT PEDAL OF THE FOOTSWITCH AND THE ACTIVATION OF THE GENERATOR CONTINUED AFTER THE DOCTOR REMOVED HER FOOT FROM THE PEDAL. AFTER SEVERAL TAPS ON THE PEDAL, THE ACTIVATION CEASED. AT THE TIME, THE HYBRIDKNIFE'S ELECTRODE WAS NOT IN CONTACT WITH PATIENT'S TISSUE AND NO CURRENT WAS DELIVERED. AS A RESULT, THERE WAS NO REPORT OF ANY PATIENT INJURY (NOTE: THERE WERE NO VISUAL SIGNS OF ANY DAMAGE OR ISSUES WITH THE FOOTSWITCH.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122519 TWO-PEDAL FOOTSWITCH; VIO®3 REMODE; BRACKET; MIDDLE PIECE FOOTSWITCH GEI ERBE ELEKTROMEDIZIN GMBH WO396336

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown