BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP EXTRA TITANIUM CLIPS

    MDR report key: 2810166 · Received October 31, 2012

    Report

    Report Number
    3005075853-2012-04932
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS OF THE CARTRIDGES (A, B, C, D, E AND F) FOUND THAT THEY WERE RECEIVED INSIDE ITS ORIGINAL PACKAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL PROCEDURE, THE CLIP WAS PLACED AND IT SEALED THE VESSEL. HOWEVER, THE CLIP BROKE IN HALF AND FELL INTO THE PATIENT. IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO 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 E4KE9X

    Patients

    Seq Age Sex Outcome Treatment
    1