BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1781990 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00573
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    December 9, 2007
    Report Date
    December 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED ANTIBACKUP, LOCK OUT SPRING OUT OF POSITION. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MCS20 INSTRUMENT FOUND THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND WOULD NOT FEED THE CLIPS AND THE ANTI-BACKUP MECHANISM WAS NOTED TO BE NON-FUNCTIONAL. UPON DISASSEMBLY OF THE INSTRUMENT, THE LOCKOUT SPRING WAS FOUND TO BE OUT OF POSITION. HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGED JAWS REPORTED ISSUE. 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 HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CABG PROCEDURE, WHEN THE SURGEON GRASPED HANDLE TO CLIP, JAW BECAME NOT TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HZ2W

    Patients

    Seq Age Sex Outcome Treatment
    1