BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2911109 · Received January 7, 2013

    Report

    Report Number
    1219930-2013-00007
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UPPER LOBE SEGMENTECTOMY. ACCORDING TO THE REPORTER: THE GUN WAS PLACED ON THE LUNG AND FIRED. WHEN THE BLACK TOGGLES PULLED BACK, THE JAWS OF THE RELOAD DID NOT OPEN. THEY WERE STUCK ON THE TISSUE. THE SURGEON HAD TO OPEN ANOTHER STAPLER AND STAPLE AROUND THE JAMMED JAWS IN ORDER TO RESECT A WIDER PORTION OF THE LUNG. THE PATIENT STATUS IS FINE; HOWEVER, THERE WAS UNANTICIPATED TISSUE LOSS. NO ADDITIONAL BLOOD LOSS OR EXTENSION TIME IN SURGERY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL: NO OTHER PATIENT DETAILS ARE AVAILABLE, AND THE REP HAS CONFIRMED THAT NO REINFORCEMENT MATERIAL WAS USED WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7977 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2C0785X

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EGIA 60 ARTICULATING MED/THICK SULU| EGIA60AMT| LOT # N2B0375ULX| EXP: 02/28/2017, MFG: 02/2012, K083519