BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE WIRELESS FOOTSWITCH

    MDR report key: 10356323 · Received August 3, 2020

    Report

    Report Number
    1221934-2020-01979
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 22, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. THE SALES REP REPORTED AN ISSUE OF THE DEVICE WOULD NOT SYNC. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, THIS COMPLAINT CAN BE CONFIRMED. DURING EVALUATION, PAIRING FAILURE WAS IDENTIFIED WITH THE DEVICE AND IT WAS DUE TO A BAD TRANSMITTER PCB. HOWEVER, SINCE THE BASE PLATE WAS CORRODED, THE DEVICE BECAME NON-REPAIRABLE. THE REPAIR WAS DECLINED AND HENCE THE DEVICE WAS NOT RESTORED TO THE SPECIFICATIONS. IT IS BEING PLACED INTO LONG TERM HOLD. THE DEFECTIVE TRANSMITTER PCB IS THE ROOT CAUSE OF THE REPORTED SYNC ISSUE. FLUID INGRESS INTO THE DEVICE AND CONTACT WITH THE BASE PLATE IS RESPONSIBLE FOR THE CORROSION OBSERVED OVER THERE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (1103043), AND NO NON-CONFORMANCE'S WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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 KNEE ARTHROSCOPY, WHILE SETTING UP FOR A KNEE SCOPE THE WIRELESS FOOT PEDAL WOULD NOT SYNC. ANOTHER PEDAL WAS BROUGHT IN WITH NO DELAY AND NO PATIENT CONSEQUENCE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BASE PLATE WAS CORRODED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819297 VAPR VUE WIRELESS FOOTSWITCH FOOT-SWITCH, ELECTRICAL GEI DEPUY MITEK LLC US 227214 10886705009657

    Patients

    Seq Age Sex Outcome Treatment
    1