BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    MDR report key: 3131386 · Received May 13, 2013

    Report

    Report Number
    1219930-2013-00375
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K102291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: RADIAL RELOAD WAS APPLIED AND FIRED WITHOUT INCIDENT. ONCE THE STAPLER WAS REMOVED A SEROSAL TEAR WAS OBSERVED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE STAPLE LINE WAS INTACT DID NOT GET ACROSS THE BOWEL ANOTHER STAPLER WAS APPLIED AND THE TEAR WAS ESSENTIALLY REMOVED. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211889 ENDO GIA MEDIUM/THICK RADIAL RELOAD DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EGIAUSHORT, EGIA ULTRA UNIVERSAL SHORT STAPLER