BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/T

    MDR report key: 1024214 · Received March 27, 2008

    Report

    Report Number
    1527736-2008-01902
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    December 11, 2007
    Report Date
    February 22, 2008
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/27/2008. DAMAGED FIRING TRIGGER TEETH/ LOCKOUT. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE ORIGINAL CARTRIDGE INSIDE THE BAG. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT TAB BENT, THE DAMAGED TO THE LOCKOUT TAB INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, AND THEN RESTARTED. WHEN THIS OCCURS, THE LOCKOUT TAB ON THE CARTRIDGE BECOMES DAMAGED. AS STATED IN THE INSTRUCTIONS FOR USE, "THE FIRING STROKE MUST BE COMPLETED. DO NOT PARTIALLY FIRE THE INSTRUMENT. FIRE THE INSTRUMENT BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. NOTE: ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE INSTRUMENT WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE INSTRUMENT". THE INSTRUMENT WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SHROUD PINION AXEL SUPPORT WAS FOUND DAMAGED. NO FUNCTIONAL TEST WAS PERFORMED. PER EVENT DESCRIPTION THE ATW35 IS A SINGLE PT DEVICE DESIGN TO BE FIRED NO MORE THAN 8 TIMES AND DOES NOT NEED OILING. 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 RESECTION PROCEDURE, THE INSTRUMENT HANDLE WAS VERY STIFF TO CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/T GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JL0M

    Patients

    Seq Age Sex Outcome Treatment
    1