BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 FOOTSWITCH *EA

    MDR report key: 13930618 · Received March 28, 2022

    Report

    Report Number
    1221934-2022-00951
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    October 26, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED IN JUAREZ LABORATORY. THE SCREWS WERE SLIGHTLY CORRODED. THE DEVICE WAS TESTED ON THE GENERATOR, AND IT WAS NOT WORKING ON ABLATE AND COAGULATE MODE. THE DEVICE WAS SENT TO MANUFACTURER FOR FURTHER INVESTIGATION. THE VAPR3 FOOTSWITCH *EA WAS RETURNED TO MANUFACTURER FOR EVALUATION. THE MANUFACTURER CONDUCTED VISUAL INSPECTION AND FUNCTIONAL TEST OF DEVICE RECEIVED BY CUSTOMER. THE VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE FOOTSWITCH IS IN A GENERALLY GOOD CONDITION, THERE IS SOME STAINING ON THE SURFACE FROM A FLUID, SCREWS SHOWS SIGNS OF CORROSION AND THERE ARE MULTIPLE IMPACT MARKS ON THE CABLE. THE FOOTSWITCH WAS CONNECTED TO A VAPR VUE GENERATOR AND SPARE ELECTRODE CONNECTED TO ALLOW CONFIRMATION OF FOOTSWITCH FUNCTIONALITY. TESTING ON THE RETURNED FOOTPEDAL CONFIRMED THAT NEITHER THE ABLATE OR COAG PEDALS WERE WORKING. A DHR REVIEW HAS BEEN PERFORMED FOR THE COMPLAINT DEVICE LOT NUMBER 1910170; NO ISSUES (NCRS OR DEVIATIONS) WITH THE MANUFACTURING PROCESS HAVE BEEN INDICATED WHICH MIGHT EXPLAIN THE FAILURES OBSERVED. BASED ON A REVIEW OF THE INVESTIGATION FINDINGS AND RA REVIEW NO CORRECTION ACTION HAS BEEN IMPLEMENTED. BASED ON THE POOR CONDITION OF THE DEVICE CABLE THE ROOT CAUSE OF FAILURE IS LIKELY DUE TO A BREAK (OPEN CIRCUIT) OF THE WIRE IN BOTH THE ABLATE & COAG CIRCUIT CAUSED BY ¿IMPACT¿ DAMAGE. THE DEVICE HAS BEEN IN CIRCULATION SINCE NOVEMBER 2019 AND IS BEYOND ITS 2-YEAR WARRANTY PERIOD. 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 · 0

    IT WAS REPORTED BY THE CUSTOMER THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3 FOOTSWITCH DEVICE WAS NOT WORKING CORRECTLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE NEITHER THE ABLATE NOR THE COAGULATE PEDALS ON THE DEVICE WERE WORKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321092 VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL HRX DEPUY MITEK LLC US 225023 1910170 10886705009114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown