BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 2001376 · Received February 25, 2011

    Report

    Report Number
    3005075853-2011-00741
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 27, 2011
    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). ADDITIONAL INFORMATION PROVIDED BY THE ACCOUNT: AFTER THE USER FACILITY MEDWATCH REPORT WAS SUBMITTED, THE SURGEON PROVIDED MORE DETAILS AROUND THE EVENT. THE DEVICE WAS ENTERED INTO THE TROCAR AS USUAL AND FIRED ACROSS THE CYSTIC DUCT. THE SURGEON INSPECTED THE CLIP TO ENSURE PROPER FORMATION (PER THE IFU) AND NOTICED THE CLIP WAS NOT COMPLETELY CLOSED DUE TO A SMALL GAP. THE CLIP WAS REMOVED AND THE SURGEON ATTEMPTED TO FIRE A SECOND CLIP IN THE SAME AREA; HOWEVER, THE HANDLES OF THE DEVICE WOULD NOT CLOSE. A SECOND DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCE TO THE PATIENT. 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; NO MALFORMED CLIPS WERE NOTED. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1