BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1714282 · Received June 3, 2010

    Report

    Report Number
    MW5016246
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING LAP ROUX-EN-Y GASTRIC BYPASS. DURING THE 11-12TH RELOAD OF STAPLES, THE DEVICE MISFIRED. THE TOP OF THE POUCH WHERE THE STAPLER MISFIRED WAS OVERSEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER NONE FZT ETHICON ENDO-SURGERY, INC. ECHELON FLEX 60 G4RV2J

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR