BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 45

    MDR report key: 3866701 · Received June 2, 2014

    Report

    Report Number
    MW5036496
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON, J & J
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SURGERY FOR PARTIAL NEPHRECTOMY. THE SURGEON STATED THAT THE DEVICE MISFIRED, RESULTING IN A TORN ARTERY, WHICH WAS REPAIRED IMMEDIATELY. THE PATIENT DID NOT SUFFER COMPLICATIONS RELATING TO THE EVENT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EXPIRATION DATE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321352 ATS 45 STAPLER GDW ETHICON, J & J UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR