BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 3042009 · Received April 2, 2013

    Report

    Report Number
    1219930-2013-00237
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PANCREAS. ACCORDING TO THE REPORTER: THE SURGEON FIRED ACROSS VESSELS. THERE WASN'T ANY EXCESSIVE BLEEDING OR ISSUES WITH THE PATIENT. ANESTHESIA HAD ISSUES WAKING THE PATIENT AND THEN BLOOD PRESSURE WAS DROPPING RAPIDLY. ANESTHESIA STARTED DOING CPR ON THE PATIENT. THE SURGEON RETURNED TO THE OPERATING ROOM AND OPENED THE PATIENT UP TO FIND OUT WHERE HE WAS BLEEDING FROM. THE PATIENT WAS STABILIZED AFTER A FEW HOURS AND THE SPLEEN WAS REMOVED. PRODUCT AND THE LOT NUMBER WAS NOT RETAINED. THE SURGEON DID NOT USE BUTTRESS MATERIAL ON THE RELOADS. THE SOURCE OF BLEEDING WAS IDENTIFIED AS THROUGH THE STAPLE LINE. THE PATIENT WAS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134858 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 030457, ENDO GIA ROTICULATOR 60-2.5 SULU| LOT #: NOT AVAILABLE