BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1163332 · Received September 10, 2008

    Report

    Report Number
    3005075853-2008-01629
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING MECHANISM. EVALUATION SUMMARY - THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE CARTRIDGE LOCK OUT TAB BENT. THE DAMAGE TO THE CARTRIDGE LOCKOUT TAB IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE 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 DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND THE TRIGGERS POST WERE FOUND DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT FIRE. THE CASE WAS COMPLETED WITH A COMPETITOR'S DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA E4L12Y

    Patients

    Seq Age Sex Outcome Treatment
    1