BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOPATH ETS

    MDR report key: 1781880 · Received July 27, 2010

    Report

    Report Number
    1781880
    Date Received
    July 27, 2010
    Date of Event
    August 25, 2009
    Report Date
    August 27, 2009
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY THE ATS 45 LINEAR STAPLER WAS BEING USED. AFTER 2ND FIRING OF STAPLES NOTHING HAPPENED,COULDN'T GET IT TO FIRE AGAIN, GUN LOCKED UP. THE 3RD FIRING FAILED TO CRIMP STAPLES TOTALLY, BUT DID CUT TISSUE. A NEW UNIT WAS USED WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY LLC ATS 45 F4P04R

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR