BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2232507 · Received August 25, 2011

    Report

    Report Number
    1219930-2011-00733
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 22, 2011
    Manufacturer
    UNITED STATES 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

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE INSTRUMENT JAMMED SHUT IN THE ABDOMEN AND COULD NOT BE RE-OPENED; OPERATION COMPLETED WITH THREAD. THERE WAS NO UNANTICIPATED TISSUE LOSS DUE TO THIS PROBLEM. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other