BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GTA 75 RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 5104524 · Received September 18, 2015

    Report

    Report Number
    MW5056447
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ETHICON
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION DURING STAPLING OF BOWEL ANASTOMOTIC SITE (GIA 75). INITIAL LOAD STAPLED CORRECTLY, FOLLOWING LOADS (2) DID NOT. REPLACED STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618954 GTA 75 RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GTA 75 RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GCJ ETHICON TLC75 M4NR6L

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR