BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED APPLIER

    MDR report key: 1782063 · Received January 24, 2008

    Report

    Report Number
    1527736-2008-00475
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Date of Event
    December 3, 2007
    Report Date
    December 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCKOUT SPRING OUT OF POSITION/DAMAGED ANTI-BACKUP. EVALUATION SUMMARY: THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED AND WOULD NOT FEED THE CLIPS AS INTENDED. UPON DISASSEMBLY, THE ANTI-BACKUP AND THE LOCKOUT SPRING WERE NOTED TO BE OUT OF POSITION. 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. 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 AXILLARY CLEARANCE PROCEDURE THE CLIPS WERE PLACED ON VESSELS. AFTER TWO OR THREE WERE PLACED THE DEVICE JAMMED AND ANOTHER DEVICE HAD TO BE OPENED TO COMPLETE THE PROCEDURE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JF40

    Patients

    Seq Age Sex Outcome Treatment
    1