BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK

    MDR report key: 7292633 · Received February 22, 2018

    Report

    Report Number
    MW5075469
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 20, 2018
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TISSUE IN THE COLON WAS TORN AS A RESULT OF USING THE COOK BIOPSY FORCEPS (REF #DBF-2.4-230-20-S). SURGEON STATED THAT THE FORCEPS WERE TEARING THE TISSUE INSTEAD OF TAKING A CLEAN BIOPSY BITE. PT'S BLEEDING WAS MINIMAL AND DID NOT REQUIRE FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131751 COOK BIOPSY FORCEPS FCL COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR