BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16624938 · Received March 27, 2023

    Report

    Report Number
    3020163307-2023-00073
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 27, 2023
    Manufacturer
    STRYKER-ENDOSCOPY TIJUANA MX
    Product Code
    KCY
    UDI-DI
    00885825016166
    PMA / PMN Number
    EXEMPT DEVIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE ENTIRETY OF THE CUFF AND BLADDER, THERE WAS A LACERATION PRESENT THAT CUT THROUGH THE STITCHING AND BLADDER. IN LIGHT OF THE INFORMATION PROVIDED BY OUR FIELD SERVICE REPRESENTATIVES, WE COULD DISLODGE BOTH OF THE O-RINGS, THEREBY CONFIRMING THE REPORTED EVENT. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. THEREFORE, THE MOST LIKELY ROOT CAUSE IS IMPROPER CONNECTION TO PUMP AND/OR MISHANDLING POST 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.- 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 · 0

    IT WAS REPORTED THE TOURNIQUET CUFF LEAK WOULD NOT FILL WITH AIR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427735 NA TOURNIQUET, PNEUMATIC KCY STRYKER-ENDOSCOPY TIJUANA MX 5921-030-235 00885825016166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown