BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 2170770 · Received July 19, 2011

    Report

    Report Number
    2170770
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THIS STAPLER MISFIRED. WAS UNABLE TO USE THE STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE SKIN STAPLER GDT ETHICON ENDO-SURGERY, INC. PXW35 H43Z96

    Patients

    Seq Age Sex Outcome Treatment
    1 *