BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5688583 · Received May 31, 2016

    Report

    Report Number
    0001056128-2016-00071
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 2, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS THE INVESTIGATION WILL BE REOPENED AND A SUPPLEMENTAL MDR WILL BE FILED. AS THE COMPLAINT DEVICE WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. DUE TO INLINE TESTING, IT IS UNLIKELY THAT THE REPORTED FAILURE MODE WAS RELEASED FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: UNDER PRESSURIZED PRESSURE TOURNIQUET CUFF. WRONG SIZE TOURNIQUET CUFF USED. KINK IN TUBING OF PRESSURE TOURNIQUET CUFF. IMPROPER CONNECTION TO PUMP. WRONG SIZE STOCKINETTE USED. STOCKINETTE IS NOT PLACED PROPERLY ON LIMB. THE INSTRUCTIONS FOR USE STATE: AVOID NEEDLES, TOWEL CLIPS, LEG HOLDERS AND OTHER EQUIPMENT THAT CAN PUNCTURE OR OTHERWISE DAMAGE THE CUFF. BEFORE BEGINNING THE PROCEDURE, VERIFY COMPATIBILITY OF ALL DEVICES AND ACCESSORIES. PRIOR TO SURGERY, SELECT THE PROPER SIZED TOURNIQUET CUFF BY MEASURING THE CIRCUMFERENCE OF THE PATIENTS' LIMB. THIS WILL AVOID PROBLEMS CAUSED BY A TOURNIQUET CUFF THAT IS TOO SMALL OR TOO LARGE. SECURE THE CUFF FASTENERS TO ENSURE THAT THE CUFF STAYS IN PLACE DURING THE PROCEDURE. IF THE PACKAGE IS DAMAGED OR IF IT WAS OPENED AND THE DEVICE WAS NOT USED, RETURN THE DEVICE AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. INSPECT THE DEVICE FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE DEVICE IF ANY DAMAGE IS NOTED. RETURN THE DEVICE AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. DEVICE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT HOLDING PRESSURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344511 NA TOURNIQUET, PNEUMATIC KCY STRYKER SUSTAINABILITY SOLUTIONS LAKELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1