BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE LOADING UNIT

    MDR report key: 3010945 · Received March 7, 2013

    Report

    Report Number
    2647580-2013-00142
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BOWEL RESECTION. ACCORDING TO THE REPORTER: THE DST GIA 80 STAPLER WAS FIRED TWICE TO COMPLETE A TRANSECTION OF THE BOWEL. THE SURGEON THEN USED THE DST GIA 80 STAPLER TO CREATE THE SIDE BY SIDE ANASTOMOSIS (THE THIRD FIRING). THE SURGEON SAID THE STAPLER FIRED FINE BUT DID A LEAK TEST AND NOTICED THERE WERE MULTIPLE LEAKS ON THE STAPLE LINE. A NURSE NOTICED THAT THE BLADE WAS HALF WAY DOWN ON THE DLU. THE SURGEON TOOK DOWN THE ANASTOMOSIS AND CREATED A LOOP ILEOSTOMY. HE WILL TAKE DOWN THE OSOTOMY IN 4-6 MONTHS. NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED. NOTHING FELL IN THE SURGICAL CAVITY. PT CURRENT STATUS REPORTED AS FINE. ADDITIONAL INFO REQUESTED VIA EMAIL. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98486 GIA 80-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P2K0229X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other