BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICH SULU

    MDR report key: 4041022 · Received August 6, 2014

    Report

    Report Number
    1219930-2014-00620
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    September 18, 2013
    Report Date
    September 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    PMA / PMN Number
    K900219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: REPORTED AS CARTRIDGE OPENED, PLACED ON TISSUE, TRIED TO FIRE AND NO STAPLES AT ALL IN THE CARTRIDGE. OPENED ANOTHER RELOAD AND IT WORKED, SO THERE WAS NO PROBLEM WITH THE GUN. THERE WERE NO STAPLES WITHIN THE NEW CARTRIDGE WHICH WAS OPENED GENDER. THERE WAS NO IRREVERSIBLE TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459201 EGIA 60 ARTICULATING MED/THICH SULU DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN N1G0546ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 GIA UNIVERSAL, K900129| 030403, LOT # UNK