BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1800414 · Received August 16, 2010

    Report

    Report Number
    3005075853-2010-04647
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 23, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE ATS45 DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED. THE DEVICE WAS RECEIVED WITH NO RELOAD LOADED IN THE DEVICE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD ON THE RIGHT ARTICULATED POSITIONS; WHEN FIRING THE STAPLES WERE MALFORMED DUE TO THE DAMAGE ARTICULATION MECHANISM. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ARTICULATION GEAR TEETH WERE FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE DAMAGE ON THE ARTICULATION GEAR, IT IS POSSIBLE THAT THE DEVICE WAS ARTICULATED BEYOND ITS ARTICULATION STOP RESULTED IN THE INSTRUMENT DAMAGE. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON PLACED THE ENDOCUTTER DOWN THE TROCAR AND ARTICULATED TO THE RIGHT WITH NO PROBLEMS. HE THEN TRIED TO ARTICULATE TO THE LEFT AND WAS UNABLE TO DO SO. HE REMOVED THE ENDOCUTTER FROM THE TROCAR AND TRIED TO ARTICULATE OUTSIDE THE PATIENT'S ABDOMEN, HE COULD TO THE RIGHT, BUT NOT TO THE LEFT. A NEW GUN FROM THE SAME BATCH WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4R210

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD PRODUCT #- TR45W