BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,4

    MDR report key: 1210140 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02463
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). RESULTS & CONCLUSIONS - DAMAGED FIRING TRIGGER TEETH. H3. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED ON HOW THE DEVICE GOT DAMAGED WITH THE INFORMATION PROVIDED, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B) (4). EVENT COULD NOT BE CONFIRMED AS NO RELOAD WAS RECEIVED FOR ANALYSIS. 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 AN OVARIAN CYST PROCEDURE, THE DEVICE WOULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,4 GDW ETHICON ENDO-SURGERY, LLC NA E4KU2M

    Patients

    Seq Age Sex Outcome Treatment
    1