BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING VAS/MED SULU

    MDR report key: 3082888 · Received April 22, 2013

    Report

    Report Number
    1219930-2013-00305
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K101444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAVH. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO STAPLE ADNEXA. AFTER IT WAS FIRED, JUST A BIT OF ADNEXA WAS LEFT. THE SURGEON ATTEMPTED TO REMOVE THE STAPLER, BUT THE JAWS DID NOT OPEN. HE HAD TO USE ANOTHER DEVICE TO RESECT REMAINING LAVH IN ORDER TO REMOVE THE RELOAD. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171526 EGIA 45 ARTICULATING VAS/MED SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2D0522ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EGIAUSTND EGIA ULTRA UNIVERSAL STAPLER:| MFG DATE: 04/2012, EXP DATE: 04/30/2017| LOT #N2D0228UKX, #K083519,