BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-2.5 SULU

    MDR report key: 2974176 · Received February 12, 2013

    Report

    Report Number
    1219930-2013-00065
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    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

    ACCORDING TO THE REPORTER: DURING THE INTERVENTION THE SULU GOT BLOCKED SHUT AND COULD NOT BE REOPENED. THE SURGEON HAD TO PERFORM A CLAMPAGE AT THE LEVEL OF THE PULMONARY ARTERY TRUNK AND FOLLOWED BY A MANUAL SUTURE. REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62336 ENDO GIA ROTICULATOR 45-2.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N1B0211LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other