BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2062109 · Received April 15, 2011

    Report

    Report Number
    2062109
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AS THE SURGEON ATTEMPTED TO "FIRE" THE DEVICE HE ENCOUNTERED GREATER THAN NORMAL "FORCE TO FIRE" RESISTANCE. THE DEVICE (STAPLER) ALSO FAILED TO FULLY RETRACT THE BLADE WHEN THE SURGEON ATTEMPTED TO RETRACT. ALSO UPON INSPECTION, THE SURGEON FOUND THAT THE "STAPLE LINE" FROM THE DEVICE WAS INCOMPLETE.MANUFACTURER RESPONSE FOR STAPLER, CUTTER, SURGICAL: TO SEND THE INSTRUMENT BACK TO COMPANY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. NTLC75 G4682L

    Patients

    Seq Age Sex Outcome Treatment
    1 *