BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC.

    MDR report key: 1369520 · Received April 23, 2009

    Report

    Report Number
    MW5010869
    Event Type
    Malfunction
    Date Received
    April 23, 2009
    Date of Event
    April 21, 2009
    Report Date
    April 23, 2009
    Manufacturer
    ETHICON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, SURGEON STATED STAPLER MISFIRED. STAPLER REMOVED FROM SERVICE. NO INJURY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC. ENDOPATH ILS / ENDOSCOPIC CURVED INTRALIUMINAL STAPLER GDW ETHICON ECS29 F4N19M

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR