BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 FOOTSWITCH *EA

    MDR report key: 11147280 · Received January 11, 2021

    Report

    Report Number
    1221934-2021-00084
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    October 21, 2020
    Report Date
    January 10, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705009114
    PMA / PMN Number
    K041135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED BY THE CUSTOMER AS FOLLOWING: THE MIDDLE BUTTON ON THE DEVICE HAS BEEN STUCK DURING AN UNKNOWN PROCEDURE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEAL THAT THE BLUE PEDAL FOR COAGULATION MODE WAS STUCK. IN ADDITION, THE DEVICE PRESENTED SEVERAL MARKS OF WEAR. BESIDES, BOTH PEDALS PRESENTED SIGNS OF CORROSION AND THE BLACK PUSH BUTTON IS MISSING. TO TEST ITS FUNCTIONALITY, THE DEVICE WAS CONNECTED TO A VAPR VUE GENERATOR AND WAS SET TO MAXIMUM POWER FOR ABLATION AND COAGULATE, AS RESULT ABLATION MODE PASS AND COAGULATION MODE FAIL. THE COMPLAINT CANNOT BE CONFIRMED. THIS DEVICE IS 9 YEARS OLD AND ITS FAILURE CAN BE ATTRIBUTED TO NORMAL FIELD WEAR OR CAN BE ASSOCIATED WITH THE INTERNAL MAGNETS OF THE PEDAL THAT CAN BE DEFECTIVE. HOWEVER, THIS CANNOT BE CONCLUSIVE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER:110042, AND NO NON-CONFORMANCES 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 CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE MIDDLE BUTTON ON THE FOOTSWITCH DEVICE WAS STUCK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BLUE PEDAL FOR COAGULATION MODE ON THE DEVICE WAS STUCK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44951 VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL HRX DEPUY MITEK LLC US 225023 1110042 10886705009114

    Patients

    Seq Age Sex Outcome Treatment
    1