BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO GIA 30

    MDR report key: 1840218 · Received September 13, 2010

    Report

    Report Number
    1840218
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 13, 2010
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING EXPLORATORY LAPAROTOMY (EXP LAP), LYSIS OF ADHESIONS, STEP (SERIAL TRANSVERSE ENTEROPLASTY) PROCEDURE AND PLACEMENT OF GASTROSOTMY TUBE. THE GIA 30 2.5MM STAPLE RELOAD DID NOT CONTAIN STAPLES. BOWEL WAS CUT VIA THE STAPLE RELOAD, BUT WAS NOT SEALED CLOSED WITH STAPLES. VICRYL SUTURES USED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30 STAPLER, RELOAD, SURGICAL GDW COVIDIEN LP * POCO393

    Patients

    Seq Age Sex Outcome Treatment
    1 7 WK