BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1973818 · Received January 14, 2011

    Report

    Report Number
    1219930-2011-00027
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DEVICE LOCKED ON TISSUE, DOCTOR HAD TO CUT AND REMOVE THE DEVICE FROM TISSUE. LIGASURE DEVICE WAS USED TO SEAL OFF THE AREA. DOCTOR WAS ABLE TO CONTINUE THE CASE. DELAY TIME REPORTED WAS 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability (B)(4)| ENDO GIA ROTICULATOR 45-2.0 SULU