BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR* 30-2.5 SULU

    MDR report key: 4248506 · Received November 13, 2014

    Report

    Report Number
    1219930-2014-01054
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: DURING A LAP APPENDECTOMY, THE 030451 RELOAD WOULD NOT OPEN AFTER FIRING. THE DEVICE WAS CUT OFF THE TISSUE IN ORDER TO BE REMOVED. THERE WAS NO BLEEDING OVER 500CC'S AND NO DELAY OVER 30 MINUTES. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733176 ENDO GIA ROTICULATOR* 30-2.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON 030451 N3G0083LX

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Disability PRODUCT NUMBER: 030449