BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3150521 · Received June 6, 2013

    Report

    Report Number
    3005075853-2013-02859
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE, THE CLIP EJECTED AT THE 1ST FIRING OUTSIDE OF THE PATIENT. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250720 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C42M

    Patients

    Seq Age Sex Outcome Treatment
    1