BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1782073 · Received January 28, 2008

    Report

    Report Number
    1527736-2008-00558
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    September 26, 2007
    Report Date
    November 30, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MCS20 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. 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. DAMAGED ANTIBACK-UP AND FEEDBAR. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS WOULD NOT ADVANCE. IT IS UNK HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, INC (CINCINNATI) NA D4HT54

    Patients

    Seq Age Sex Outcome Treatment
    1