BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5632454 · Received May 4, 2016

    Report

    Report Number
    0001056128-2016-00057
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 18, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS. THEREFORE, 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 SINCE THE LOT WAS NOT REPORTED. THE REPORTED EVENT COULD BE ATTRIBUTED TO AN UNDER PRESSURIZED PRESSURE TOURNIQUET CUFF, WRONG SIZE TOURNIQUET CUFF USED, KINK IN TUBING, IMPROPER CONNECTION TO PUMP, WRONG SIZE STOCKINETTE USED, OR STOCKINETTE WAS NOT PLACED PROPERLY ON LIMB. THE INSTRUCTIONS FOR USE STATE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING AIR AND WOULD NOT HOLD PRESSURE DURING THE CASE. THE DEVICE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287204 NA TOURNIQUET, PNEUMATIC KCY STRYKER SUSTAINABILITY SOLUTIONS LAKELAND

    Patients

    Seq Age Sex Outcome Treatment
    1