BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE

    MDR report key: 1822365 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05438
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    July 3, 2007
    Report Date
    July 3, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ARTICULATION GEAR TEETH. EVAL SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED. THE DEVICE WAS RECEIVED WITH A CARTRIDGE LOADED IN THE DEVICE; THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. THE RETURNED CARTRIDGE WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE ON THE 3 ARTICULATED POSITIONS; WHEN FIRED TO THE LEFT AND CENTER THE STAPLES WERE MALFORMED DUE TO THE DAMAGE ARTICULATION MECHANISM, HOWEVER, WHEN FIRE IN THE RIGHT POSITION THE STAPLE FORMATION WAS CONFORMING. 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% 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). 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 TAH/BSO PROCEDURE, THE ARTICULATION BAND BROKE. THE STAPLER WOULD NOT ARTICULATE ANYMORE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4GV1N

    Patients

    Seq Age Sex Outcome Treatment
    1