BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD

    MDR report key: 4549034 · Received February 26, 2015

    Report

    Report Number
    1219930-2015-00137
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 18, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: FINAL FIRING ACROSS THE STOMACH, IT DID NOT COMPLETE THE FIRING AS IT DID NOT FIRE ALL THE WAY. THE LAST 2 MM OF THE DEVICE DID NOT STAPLE. THERE WAS NO UNANTICIPATED TISSUE LOSS AND THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE AND SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136197 ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIATRS60AMT N5A0100UKX

    Patients

    Seq Age Sex Outcome Treatment
    1