BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 3188083 · Received June 19, 2013

    Report

    Report Number
    1219930-2013-00458
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: AT THE END OF THE CASE THE SCRUB TECH SAW A SCREW ON THE SCRUB TABLE NEXT TO THE ENDO GIA ULTRA XL BELIEVED TO BE A RIVET FROM THE HINGE PORTION OF THE BLACK LOAD WHICH WAS ATTACHED TO THE STAPLER. ATTEMPTS WERE MADE BY THE SURGEON AND THE NURSES TO FIND A SECOND RIVET WHICH WAS ALSO NOTED TO BE MISSING. IT COULD NOT BE LOCATED. THERE HAS BEEN NO ADVERSE EFFECTS INVOLVED AND PATIENT REPORTED. THE NURSE DID SAY THAT WHEN SHE LOADED AND CYCLED THE INSTRUMENT IT WAS SCRATCHY AND DID NOT FEEL SMOOTH. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279461 EGIA ULTRA UNIVERSAL XL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3D0263UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EGIA 60 ARTICULATING XTRA THICK SULU, K083519| (B)(4)