BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 10786160 · Received November 4, 2020

    Report

    Report Number
    0001056128-2020-00080
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 4, 2020
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    KCY
    UDI-DI
    00885825016173
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE CUFF WAS FOUND TO BE NON-HERMETIC. AIR WAS FOUND ESCAPING FROM A SLIT IN THE BLADDER. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. THE REPORTED EVENT COULD BE ATTRIBUTED TO: PTC COMING INTO CONTACT WITH SHARP OBJECT OR SURFACE. PRODUCT DAMAGED DURING SHIPPING/ STORAGE. FAILURE MODE: LOSS OF STRUCTURAL INTEGRITY. INADEQUATE HANDLING, USER DAMAGES CUFF. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE TOURNIQUET CUFF WOULD NOT INFLATE. THE ANCILLARY EQUIPMENT WAS SWAPPED OUT AND THERE WAS NO IMPROVEMENT. THE PHYSICIAN USED AN ESMARK BANDAGE TO TIE OFF THE SURGICAL SITE. THERE WAS NO BREAKTHROUGH OR EXCESSIVE BLEEDING. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 15 TO 20 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252808 NA TOURNIQUET, PNEUMATIC KCY STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 5921-034-135 UNKNOWN 00885825016173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention