BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 19669895 · Received July 3, 2024

    Report

    Report Number
    3020163307-2024-00003
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 3, 2024
    Manufacturer
    STRYKER-ENDOSCOPY TIJUANA MX
    Product Code
    KCY
    UDI-DI
    00885825013868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE CONNECTOR JUNCTIONS, REVEALED SEPARATION. THE CONNECTORS APPEARED TO BE IN-TACT WITH NO VISUAL INDICATION OF DAMAGE. THE TUBING WAS CLEAR WITH NO VISUAL KINKS, BENDS, OR DISTRESS. THE ENTIRETY OF THE CUFF APPEARED TO BE INTACT WITH NO OBVIOUS SIGNS OF RIPS, TEARS, PILLING, FRAYING, OR LACERATIONS. UPON FUNCTIONAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE CUFF HAD AN AUDIBLE LEAK WHICH WAS PINPOINTED TO THE ELBOW JUNCTION. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. STRYKER PROCEDURE(S) SUPPORT(S) THAT THE DEVICE WAS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THE MOST LIKELY ROOT CAUSE IS MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER'S SUSTAINABILITY SOLUTIONS. 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 · 0

    IT WAS REPORTED THAT THE TOURNIQUET CUFF FAILED. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467174 NA TOURNIQUET, PNEUMATIC KCY STRYKER-ENDOSCOPY TIJUANA MX 60-7070-105 UNKNOWN 00885825013868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown