BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS45 ENDO LINEAR CUTTER 45MM

    MDR report key: 1080012 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00534
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE DID NOT FIRE THE STAPLE CARTRIDGE ON THE APPENDIX STUMP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS45 ENDO LINEAR CUTTER 45MM NONE GDW ETHICON ENDO-SURGERY, LLC. NA D4JY8T

    Patients

    Seq Age Sex Outcome Treatment
    1