BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 725892 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02618
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    March 27, 2006
    Report Date
    March 28, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE ANALYSIS FINDING OF DAMAGED FIRING TRIGGER TEETH, THIS FILE IS CONSIDERED TO BE REPORTABLE. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE 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. IN ADDITION, THE INSTRUCTIONS FOR USE STATE, " THE FIRING STROKE MUST BE 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. FING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE." 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 AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 510(K) IS K020779

    Description of Event or Problem · 1

    DURING A GYN PROCEDURE, THE DEVICE WOULD NOT CLOSE IT WAS NOT USED, PULLED NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER GDW KOG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN