BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1781988 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00576
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    September 8, 2007
    Report Date
    October 19, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MCL20 INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND WOULD NOT FEED THE CLIPS AND THE ANTI-BACKUP WAS NOTED TO BE NON-FUNCTIONAL. UPON DISASSEMBLY OF THE INSTRUMENT THE FEEDBAR WAS FOUND TO BE BENT AND DISENGAGED FROM THE FEEDBAR DRIVER THEREFORE NOT ALLOWING THE PROPER FEEDING OF THE CLIPS INTO THE JAWS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND DAMAGE. ADDITIONALLY THE CARTRIDGE COVER WAS NOTED TO BE CRACKED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLIPS WOULD NOT ADVANCE. PROCEDURE: PROSTATECTOMY. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA V4H82T

    Patients

    Seq Age Sex Outcome Treatment
    1