BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS-FLEX45

    MDR report key: 1905311 · Received June 28, 2010

    Report

    Report Number
    1905311
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER WOULD NOT FIRE.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ENDOPATH ETS-FLEX45: REPRESENTATIVE IS AWARE AND SAID THAT HE WILL COME AND PICK UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS-FLEX45 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC * G4RN5A

    Patients

    Seq Age Sex Outcome Treatment
    1 *