BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM

    MDR report key: 1203766 · Received October 10, 2008

    Report

    Report Number
    3005075853-2008-02271
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED PAWL PIN. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITHOUT A RELOAD PRESENT. THE RETURNED DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE PIN PAWL WAS NOTED TO NOT BE PROPERLY FLARED, CAUSING THE FIRING MECHANISM NOT TO PROPERLY OPERATE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES RELATED TO THE EVENT DESCRIPTION WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE MISFIRED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM GDW ETHICON ENDO-SURGERY, LLC NA E4L81T

    Patients

    Seq Age Sex Outcome Treatment
    1