BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3170603 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03028
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 30, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT FIRING DID THE CLIPS DROP FROM THE DEVICE? YES. WAS THERE ANY TORQUING OR TWISTING WHEN THEY WERE FIRING THE DEVICE? UNKNOWN. WERE THERE ANY UNUSUAL NOISES HEARD WHEN THEY WERE USING THE DEVICE? UNKNOWN. HAS THE SURGEON USED THE DEVICE BEFORE? YES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT INSTRUMENT (A) 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, FED, AND FORMED FIVE CLIPS AS INTENDED AND IT EJECTED EIGHT CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE (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 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. BATCH # J91L5Y (MFG DATE: 06/30/2012 EXP DATE: 05/30/2017).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-EN-Y BYPASS PROCEDURE, WHEN ADVANCING A CLIP TO BE FIRED, THE CLIP WOULD FALL OUT OF THE JAW. ALL FALLEN CLIPS WERE RETRIEVED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271346 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1