BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED APPLIER

    MDR report key: 1831419 · Received December 20, 2007

    Report

    Report Number
    1527736-2007-08704
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE ANALYSIS INSTRUMENT FOUND THAT IT WAS RETURNED WITH A PIECE OF FOREIGN MATTER INSIDE THE CLIP TRACK, THE CARTRIDGE COVER WAS NOTED TO BE BROKEN AND CRACKED AND THE HANDLES WERE FOUND TO BE CRACKED. THE INSTRUMENT WAS CYCLED AND WOULD NOT FED THE CLIPS. THE INSTRUMENT WAS DISASSEMBLED AND THE LOCKOUT SPRING WAS FOUND TO BE OUT OF POSITION, THE FEEDBAR WAS FOUND TO BE DISENGAGED FROM THE FEEDBAR DRIVER THEREFORE CAUSING THE FEEDING ISSUE. UPON FURTHER INSPECTION THE FOREIGN MATTER WAS DETERMINED TO BE THE TIP OF A PENCIL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND DAMAGE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS WERE NOT ADVANCING DURING A LIVER RESECTION PROCEDURE. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED APPLIER GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1