BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - VASCULAR/THIN

    MDR report key: 1781992 · Received January 24, 2008

    Report

    Report Number
    1527736-2008-00491
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Report Date
    January 4, 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 Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL SUMMARY: THE ANALYSIS SHOWED THAT 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 SPRING CARTRIDGE LOCK OUT DAMAGED. THE DAMAGE TO THE SPRING CARTRIDGE LOCKOUT 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. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE." THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE CLAMPING AND FIRING MECHANISM WERE 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 BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A DEVICE WITH NO DESCRIPTION OF FAILURE. THERE IS NO OTHER INFO AVAILABLE. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - VASCULAR/THIN GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1