BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 11398692 · Received March 2, 2021

    Report

    Report Number
    0001056128-2021-00011
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    March 4, 2020
    Report Date
    March 2, 2021
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE DEVICE CATALOG NUMBER WAS REPORTED AS 5921-044-701 IN THE MAUDE REPORT. 5921-044-701 IS NOT A VALID STRYKER SUSTAINABILITY SOLUTIONS CATALOG NUMBER. THEREFORE THE, CATALOG NUMBER IS UNKNOWN. THE REPORTED EVENT WAS IDENTIFIED THROUGH A MAUDE DATABASE REVIEW AND NO FACILITY OR LOT INFORMATION WAS PROVIDED. THEREFORE, THE DEVICE COULD NOT BE RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS AND NO DEVICE EVALUATION OR FOLLOW-UP COULD BE PERFORMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. AS THE COMPLAINT DEVICE WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) STATE: WARNINGS: IT IS IMPORTANT THAT THE TOURNIQUET CUFF BE APPLIED AT THE PROPER LOCATION WITH ADEQUATE PRESSURE FOR THE APPROPRIATE AMOUNT OF TIME. AVOID NEEDLES, TOWEL CLIPS, LEG HOLDERS AND OTHER EQUIPMENT THAT CAN PUNCTURE OR OTHERWISE DAMAGE THE CUFF. DIRECTIONS FOR USE: 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 PATIENT'S 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. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRESSURE TOURNIQUET CUFF FAILED TO INFLATE. THE REPORTED EVENT WAS IDENTIFIED THROUGH A MAUDE DATABASE REVIEW AND NO FACILITY OR LOT INFORMATION WAS PROVIDED. THEREFORE NO ADDITIONAL FOLLOW UP WAS ABLE TO BE CONDUCTED. THE REPORT INDICATED THERE WERE NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295544 NA TOURNIQUET, PNEUMATIC KCY STRYKER SUSTAINABILITY SOLUTIONS LAKELAND

    Patients

    Seq Age Sex Outcome Treatment
    1