BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED

    MDR report key: 1821675 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04975
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES A, B AND C WERE RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICES WERE TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICES WERE CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. DEVICE D WAS RETURNED EMPTY AND LOCKED OUT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS RELOADED WITH 30 NEW CLIPS. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE CLIPS AS INTENDED. THE DEVICES WERE FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS COULD NOT BE FIXED ON THE VESSELS. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA MED CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA G4T69G

    Patients

    Seq Age Sex Outcome Treatment
    1