BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1810025 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07551
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 9, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL SUMMARY - THE ANALYSIS RESULTS FOR THE MCM20 INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE CLIP WAS INCORRECTLY LOADED INTO THE CLIP TRACK; THEREFORE THE REMAINING CLIPS WOULD NOT BE FED INTO THE JAWS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CABG PROCEDURE, THE CLIPS GOT BLOCK IN THE MECHANISM DURING APPLICATION. THEY OPENED A NEW INSTRUMENT. INSTRUMENT BEING RETURNED FOR ANALYSIS. THERE WAS NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4J235

    Patients

    Seq Age Sex Outcome Treatment
    1