BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** TITANIUM LIGATING CLIPS

    MDR report key: 2961922 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00627
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    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). THE ANALYSIS RESULTS OF FIVE CARTRIDGES WERE RECEIVED INSIDE THEIR ORIGINAL PACKAGE. ONE OF THE CARTRIDGE WAS OPENED AND TESTED FOR FUNCTIONALITY IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT. UPON EVALUATION, THE CLIPS WERE LOADED, RETAINED AND PROPERLY FORMED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS DID NOT CLOSE CORRECTLY. COULD BE REMOVED, NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65009 LIGACLIP** TITANIUM LIGATING CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AW71

    Patients

    Seq Age Sex Outcome Treatment
    1