BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1033971 · Received April 24, 2008

    Report

    Report Number
    MW5006397
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ETHICON CORPORATE HEADQUARTERS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ETHICON FLEX45 ARTICULATING LINEAR CUTTER STAPLED THE LUNG TISSUE, BUT DID NOT CUT. THERE WAS SOME BLEEDING. THE SURGEON JUST RE-STAPLED THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH ETS FLEX45 ARTICULATING LINEAR CUTTER GCJ ETHICON CORPORATE HEADQUARTERS ATG45 D4JY0R

    Patients

    Seq Age Sex Outcome Treatment
    1