BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF

    MDR report key: 10913677 · Received November 27, 2020

    Report

    Report Number
    10913677
    Event Type
    Malfunction
    Date Received
    November 27, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 20, 2020
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS OPEN TO THE STERILE FIELD, THE CLEAR PLASTIC SHEET THAT WRAPS AROUND THE ANASTOMOSIS SITE WAS NOT CONNECTED TO THE FLOW PROBE CORD. THIS WAS NOTICED PRIOR TO ATTEMPT TO IMPLANT INTO PATIENT. THERE WAS NO PATIENT HARM. A NEW IMPLANT WAS OPENED AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378296 COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF TRANSDUCER, ULTRASONIC JOP COOK VANDERGRIFT INC. G21363 N174161

    Patients

    Seq Age Sex Outcome Treatment
    1