BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3170633 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03029
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 30, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. 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 ANALYSIS RESULTS FOUND THAT INSTRUMENT (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, AND EJECTED 18 CLIPS AND FED AND FORMED 2 CONFORMING CLIPS. NO SCISSORING ISSUES WERE NOTED DURING ANALYSIS. FINALLY, IT LOCKED OUT AS INTENDED. 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. BATCH # K90324, MFG DATE 01/17/2013, EXP DATE 12/17/2017.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN APPENDECTOMY PROCEDURE, THE DEVICE WAS USED TO PLACE CLIPS ON MESENTERY. THE CLIPS CAME OUT THE BRANCHES AND THEY "CROSSED". ANOTHER LIKE 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
    271579 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AX9G

    Patients

    Seq Age Sex Outcome Treatment
    1