BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE WIRELESS FOOTSWITCH

    MDR report key: 13660353 · Received March 3, 2022

    Report

    Report Number
    1221934-2022-00704
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 16, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS FOR DEVICE RETURN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (1103088), AND NO NON-CONFORMANCE WAS IDENTIFIED. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. 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. H4: DEVICE MANUFACTURE DATE HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR VUE WIRELESS FOOTSWITCH DEVICE WAS INTERMITTENTLY NOT CONNECTING TO THE GENERATOR DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312277 VAPR VUE WIRELESS FOOTSWITCH FOOT-SWITCH, ELECTRICAL GEI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown