BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1831638 · Received January 8, 2008

    Report

    Report Number
    1527736-2008-00143
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    October 29, 2007
    Report Date
    November 20, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE ANVIL IN THE CLOSE POSITION AND EXTENDED AS THE ANVIL CRIMP WAS NOTED TO BE INSUFFICIENT. A CARTRIDGE WAS RECEIVED LOADED ON THE DEVICE AND VOID OF STAPLES; IN ADDITION THE ARTICULATION MECHANISM OF THE DEVICE WAS DAMAGED. THE ANVIL WAS MANUALLY REINSERTED ON THE DEVICE AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE ON THE 3 ARTICULATION MECHANISM. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ARTICULATION GEAR TEETH WERE FOUND BROKEN. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DID NOT FIRE PROPERLY. COMPLETED THE CASE WITH THE SAME LIKE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE LINE -2.5 GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HU1Y

    Patients

    Seq Age Sex Outcome Treatment
    1