BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR.THIN) - 35 MM

    MDR report key: 1112639 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01035
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED INTO THE DEVICE AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. 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 LAP NEPHRECTOMY PROCEDURE, AFTER THE DEVICE WAS INSERTED THROUGH THE TROCAR, THE CARTRIDGE FELL OUT. IT WAS RETRIEVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR.THIN) - 35 MM GDW ETHICON ENDO-SURGERY, LLC NA C4E88X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK