BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 FOOTSWITCH *EA

    MDR report key: 11728312 · Received April 26, 2021

    Report

    Report Number
    1221934-2021-01333
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 9, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY - ACCORDING TO THE INFORMATION RECEIVED, IT WAS WORKING INTERMITTENTLY DURING A SHOULDER PROCEDURE. THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED AND PHOTO PROVIDED BY CUSTOMER. THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. VISUAL OBSERVATION SHOWED A LOT OF MARKS INDICATED THAT IT WAS WORN. SOME AREAS OF THE DEVICE WERE PEELED; ALSO, THE BUTTON WAS CRACKED AND WITHOUT ITS CAP. THE ENTIRE DEVICE WAS DIRTY AND HAD CORROSION MARKS. IT WAS FOUND THAT THE CORD HAD A CUT, AND THE CABLES WERE EXPOSED. FINALLY, THE PINS WERE BENT; THEREFORE, CANNOT BE CONNECTED INTO THE PUMP. THE PHOTO PROVIDED BY THE CUSTOMER SHOWED THE INFORMATION ON THE BACK OF THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [0812007] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FUNCTIONAL TEST WAS NOT PERFORMED; THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURED DATE OF THIS DEVICE IS 2008 AND HENCE INDICATES THIS DEVICE IS 12 YEARS OLD. THE POSSIBLE ROOT CAUSE FOR THE BENT PINS CAN BE ATTRIBUTED TO THE HEAVY USE WHILE TRYING TO CONNECT AND DISCONNECT IN THE CONNECTION POINT. THE WEAR CONDITION CAN BE RELATED TO FAIR WEAR AND TEAR DUE TO AGE AND USE, AS WELL AS ROUGH USE. AS PER IFU-103095 IT IS IMPORTANT TO ENSURE THE MAINTENANCE, THE FOOTSWITCH CANNOT BE STERILIZED. THE FOOTSWITCH SURFACES CAN BE CLEANED WITH DETERGENTS AND DISINFECTANT CLEANERS ACCORDING TO STANDARD HOSPITAL PRACTICES. AS PART OF MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE FOOTSWITCH DEVICE WAS WORKING INTERMITTENTLY. THERE WAS AN UNSPECIFIED MINOR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621563 VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL HRX DEPUY MITEK LLC US 225023 0812007 10886705009114

    Patients

    Seq Age Sex Outcome Treatment
    1