BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURG

    MDR report key: 1840182 · Received September 15, 2010

    Report

    Report Number
    MW5017441
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 9, 2010
    Manufacturer
    JOHNSON: JOHNSON - ETHICON ENDO SURG
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC COLON RESECTION "STAPLER" WOULD NOT FIRE. THIS THEN RESULTED IN USE OF 4.0 SILK SUTURE BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURG ETS FLEX 60 ENDOSCOPIC ARTICULATING LONG LINEAR CUTTER GDW JOHNSON: JOHNSON - ETHICON ENDO SURG LTS60A G4TA0R

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR