BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC APPLIER

    MDR report key: 3190317 · Received June 26, 2013

    Report

    Report Number
    3005075853-2013-03288
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 20, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING REQUIREMENTS. 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 WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, FROM THE FIRST DAY, THE JAWS OF THE APPLIER WERE LOOSE WHICH WAS LEADING TO MALFORMATION OF CLIPS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289615 LIGACLIP** ENDOSCOPIC APPLIER FZP ETHICON ENDO-SURGERY, LLC. NA A8527

    Patients

    Seq Age Sex Outcome Treatment
    1