BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2922496 · Received January 14, 2013

    Report

    Report Number
    1219930-2013-00042
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 21, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: AFTER THE FIRING THE TRIGGER BROKE AND THE STAPLES DEPLOYED INTO A CLUSTER ON THE TISSUE, DOCTOR USED A SECOND (B)(4) AND RELOAD AND TRIED TO FIRE OVER THE STAPLES ON THE TISSUE HE NOTICED THAT THE STAPLES DID NOT FORM CORRECT. SWITCHED TO AN OPEN PROCEDURE. PT STATES IS OK. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS EXTENDED BY MORE THAN 45 MINUTES. NO REINFORCEMENT MATERIAL WAS USED DURING THE CASE. ADDITIONAL INFO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20873 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GAG COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R