BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1870642 · Received October 7, 2010

    Report

    Report Number
    MW5017716
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE STAPLER DURING THE PROCEDURE, THE RELOAD MISFIRED AND THEN FELL OUT OF THE STAPLER INTO THE PATIENT. THE RELOAD WAS RETRIEVED AND REMOVED FROM THE SURGICAL FIELD. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH ETS-FLEX 45 STAPLER GDW ETHICON ENDO-SURGERY, LLC ATS45 G4TM6Y

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Disability