BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1083019 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00643
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/23/2008. FIRING TRIGGER TEETH BROKEN. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE INSTRUMENT AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE INSTRUMENT WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH WERE FOUND DAMAGED. ALTHOUGH WE WERE UNABLE TO CONCLUDE WHAT CAUSED THE DAMAGED, PLEASE NOTE THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE RELEASE CRITERIA PRIOR TO SHIPMENT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE MISFIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA E4KY4W

    Patients

    Seq Age Sex Outcome Treatment
    1