BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 FOOTSWITCH *EA

    MDR report key: 8741913 · Received June 27, 2019

    Report

    Report Number
    1221934-2019-57452
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705009114
    PMA / PMN Number
    K041135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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 RECEIVED AND INSPECTED. VISUAL OBSERVATION REVEALED THE MODE BUTTON WAS MISSING. ADDITIONALLY, THE WIRE WAS FRAYED AS REPORTED BY THE CUSTOMER. HENCE, THE DEVICE WAS NOT TESTED DUE TO SAFETY REASONS. THE COMPLAINT FOR THE CORD DAMAGED IS CONFIRMED. HOWEVER, WE CAN NOT CONFIRM THE FUNCTIONALITY OF THE DEVICE, AS IT WAS NOT TESTED. FURTHERMORE, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 1801088, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FRAYED WIRE COULD BE THE POTENTIAL ROOT CAUSE WHICH LED THE CUSTOMER TO EXPERIENCE THE DEVICE NOT FUNCTIONING AS INTENDED. WE CANNOT DETERMINE A ROOT CAUSE FOR THE FRAYED WIRE, HOWEVER IT IS POSSIBLE THAT THIS FAILURE CAN BE ATTRIBUTED TO USER MISHANDLING OF THE DEVICE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). REPORTER IS SALES CONSULTANT. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE VAPR 3 FOOTSWITCH DID NOT WORK AND HAD A FRAYED WIRE. THE CASE WAS COMPLETED WITH ANOTHER VAPR FOOTSWITCH WITHOUT PATIENT HARM, BUT THERE WAS A TWO TO THREE MINUTE SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534630 VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL HRX DEPUY MITEK LLC US 1801088 10886705009114

    Patients

    Seq Age Sex Outcome Treatment
    1