BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE WIRELESS FOOTSWITCH

    MDR report key: 10854478 · Received November 17, 2020

    Report

    Report Number
    1221934-2020-03522
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 17, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009657
    PMA / PMN Number
    K100638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE VAPR VUE WIRELESS FOOTSWITCH WAS NOT WORKING, WAS UNABLE TO BE CONFIRMED. THE DEVICE WAS HOWEVER FOUND TO BE CORRODED. THE REPAIR OF THE DEVICE WAS DECLINED AND WAS PLACED INTO LONG TERM HOLD DUE TO CORROSION. FLUID INGRESS INTO THE DEVICE IS THE ROOT CAUSE OF THE CORROSION OF THE FOOT SWITCH. THIS WOULD HAVE IN TURN, CAUSED THE DEVICE TO NOT FUNCTION AS INTENDED BY THE CUSTOMER, HOWEVER, SINCE THE REPORTED CONDITION WAS NOT CONFIRMED, THE ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL : (B)(4), LOT : 1103088), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING TESTING, IT WAS OBSERVED THAT THE FOOTSWITCH DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS CORRODED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322791 VAPR VUE WIRELESS FOOTSWITCH FOOT-SWITCH, ELECTRICAL GEI DEPUY MITEK LLC US 227214 10886705009657

    Patients

    Seq Age Sex Outcome Treatment
    1