BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP**

    MDR report key: 1812661 · Received August 24, 2010

    Report

    Report Number
    3005075853-2010-04821
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT USE ON THE PATIENT. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS 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. HOWEVER, IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. 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 OUTER BLISTER OF THIS PACKAGING WAS SEALED ON THREE SIDES, ONE SIDE WAS UNSEALED. INNER STERILE BARRIER WAS INTACT, INSTRUMENT WAS THEN USED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE "DEPARTURE AND SKEW". 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** CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4NF8X

    Patients

    Seq Age Sex Outcome Treatment
    1