BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON-PROXIMATE 75MM BLUE RELOAD

    MDR report key: 19850961 · Received July 26, 2024

    Report

    Report Number
    MW5157720
    Event Type
    Other
    Date Received
    July 26, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 75MM LINEAR CUTTER REF TLC75 FROM ETHICON. WHEN USING THIS PRODUCT, THE PRODUCT DID NOT FIRE A STAPLER AS INTENDED. "THE CUTTER STOPPED HALFWAY AND DID NOT ALLOW FOR A FULL DISCHARGE" A SECOND 75MM LINEAR CUTLER WAS OPENED AND HAD THE SAME ERROR. MD STATED, "YES, THERE WAS INJURY TO THE PATIENT, AS 10CM MORE BOWEL HAD TO BE RESECTED THAN COULD HAVE BEEN". REFERENCE REPORT: MW5157721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965343 ETHICON-PROXIMATE 75MM BLUE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC TLC75

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability