BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP EXTRA TITANIUM CLIPS

    MDR report key: 2800263 · Received October 22, 2012

    Report

    Report Number
    3005075853-2012-04807
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    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). THE ANALYSIS RESULTS OF THE CARTRIDGE (A, B, C, D, E, F, I, K AND L) FOUND THAT IT WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. A DROP TEST WAS PERFORMED AND NO LOOSE CLIPS WERE NOTED. UPON EVALUATION, THE CLIPS WERE LOADED, RETAINED AND PROPERLY FORMED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF THE DEVICE (G, H, J AND M) FOUND THAT IT WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. A DROP TEST WAS PERFORMED AND NO LOOSE CLIPS WERE NOTED. DURING TESTING, THE COVER GOT PARTIALLY DETACHED FROM THE BASE. HOWEVER, THE CLIPS WERE LOADED, RETAINED AND PROPERLY FORMED. THE LATCHING FEATURE WAS EVALUATED AND ONE TAB WAS FOUND TO BE DAMAGED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED CARTRIDGE ISSUES. 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 WILL NOT CLOSE CORRECTLY. 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 EXTRA TITANIUM CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AH8M

    Patients

    Seq Age Sex Outcome Treatment
    1