BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-4.8 SULU

    MDR report key: 3955179 · Received July 21, 2014

    Report

    Report Number
    2647580-2014-00543
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    July 1, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SMALL BOWEL RESECTION. ACCORDING TO THE REPORTER: DURING PROCEDURE, THE DEVICE CORRECTLY STAPLED AND CUT BUT IT GOT STUCK SHUT ON TISSUE. THE SURGEON HAD TO CUT THE TISSUE TO FREE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426631 ENDO GIA II 60-4.8 SULU DISPOSSABLE SUGICAL STAPLIGN DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MFR DATE: 05/01/2013, EXP DATE: 05/31/2018| GIA UNIVERSAL: CAT #030403, LOT #N3E0572X, K900129