BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA

    MDR report key: 6812652 · Received August 23, 2017

    Report

    Report Number
    6812652
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING AN ENDO GIA ULTRA UNIVERSAL STAPLER 12MM (REF: EGIAUSTND) WITH A 30MM 3.5 LOAD (CATALOG #030419). SURGEON WENT TO FIRE IT, AND IT ONLY CUT AND DID NOT LAY DOWN STAPLES, CAUSING DAMAGE TO THE BOWEL. ANOTHER STAPLER OBTAINED TO COMPLETE SURGERY. PATIENT BEING MONITORED. PROCEDURE WAS EXPLORATORY LAPAROSTOMY, TOTAL ABDOMINAL COLECTOMY, RECONSTRUCTION WITH ILEAL POUCH ANAL ANASTOMOSIS, AND DIVERTING LOOP ILEOSTOMY. PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593838 GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP GIA6038S

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR