BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1250606 · Received November 14, 2008

    Report

    Report Number
    3005075853-2008-03038
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 10, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICULATION MECHANISM DAMAGED. EVALUATION SUMMARY - THE ANALYSIS SHOWED THAT THE 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 LEFT ARTICULATED POSITIONS; WHEN FIRE 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 BROKEN. WHILE NO CONCLUSION COULD BE REACH 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% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. 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 LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS USED TO GO ACROSS A VERY THICK COLON. THE DEVICE HAD BEEN FIRED THREE TIMES. ON THE FOURTH ATTEMPT, THE DEVICE SEEMED TO JAM, AND WOULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 - 4 GDW ETHICON ENDO-SURGERY, LLC NA E4L278

    Patients

    Seq Age Sex Outcome Treatment
    1