BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1782001 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00575
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    January 3, 2007
    Report Date
    January 3, 2008
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE MCS20 WAS RETURNED WITH THE ANTIBACK UP DAMAGED. THE INSTRUMENT WOULD NOT FEED THE CLIPS DURING FUNCTIONAL TESTING. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT. 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 DURING AN UNK PROCEDURE THAT THE CLIPS WOULD NOT ADVANCE. ANOTHER LIKE DEVICE WAS USED. 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 D4JJ9H

    Patients

    Seq Age Sex Outcome Treatment
    1