BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5

    MDR report key: 1130404 · Received August 20, 2008

    Report

    Report Number
    3005075853-2008-01301
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND NO RELOAD PRESENT. THE INSTRUMENT WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN, NO FUNCTIONAL TEST WAS PERFORMED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED TO REPORTED INCIDENT, AS THERE WAS NO RELOAD RETURNED FOR ANALYSIS. A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO FIRE AND WOULD NOT CUT OR STAPLE. THE HANDLE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5 GDW ETHICON ENDO-SURGERY, LLC NA E4K17T

    Patients

    Seq Age Sex Outcome Treatment
    1