BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1820136 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07198
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    July 7, 2007
    Report Date
    October 11, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP; DAMAGED FEEDBAR. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MCL20 INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED, FED AND FORMED 7 CONFORMING CLIPS AND 2 SHORT FED CLIPS. UPON DISASSEMBLY OF THE INSTRUMENT THE FEEDBAR WAS FOUND TO BE BENT 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 DAMGE. 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 RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIP APPLIER DOES NOT ADVANCE THE CLIP AS IT IS SUPPOSED TO DO. NO FURTHER INFORMATION IS AVAILABLE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4H02L

    Patients

    Seq Age Sex Outcome Treatment
    1