BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16709864 · Received April 10, 2023

    Report

    Report Number
    3020163307-2023-00189
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 10, 2023
    Manufacturer
    STRYKER-ENDOSCOPY TIJUANA MX
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION AS THE DEVICE WAS DISCARDED. AS THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS, EVALUATION WAS UNABLE TO BE PERFORMED. NO DEVICE INFORMATION WAS REPORTED AND THE CUSTOMER DID NOT REPORT LOT # OR SERIAL # INFORMATION. THEREFORE, THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VERIFIED. THE MOST LIKELY ROOT CAUSE IS IMPROPER CONNECTION TO PUMP. 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 · 0

    IT WAS REPORTED THE DEVICE WAS DEFECTIVE AND LEAKING DURING USE. 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
    1820834 NA TOURNIQUET, PNEUMATIC KCY STRYKER-ENDOSCOPY TIJUANA MX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown