BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGOPSY BACKLOADING BIOPSY FORCEPS

    MDR report key: 15051657 · Received July 19, 2022

    Report

    Report Number
    15051657
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    July 14, 2022
    Report Date
    July 15, 2022
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE BIOPSY FORCEPS WOULD NOT BITE AND CUT THE TISSUE, WHEN PULLING BACK ON THE TISSUE WAS NOT ABLE TO PULL THE TISSUE AWAY. A NEW BIOPSY WAS OPENED AND WORKED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333720 BIGOPSY BACKLOADING BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL COOK MEDICAL LLC G48240 C1868235

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA Male