BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3830331 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03526
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: AT WHAT FIRING DID THE ISSUE OCCUR? CYSTIC DUCT AND CYSTIC ARTERY, SURGEON DID CHECK FOR PRESENCE OF GALL STONES AS HE WONDERED IF THAT COULD HAVE CONTRIBUTED TO THE FAILURE OF CLIP FORMATION BUT THERE WERE NO STONES PRESENT. WAS THERE ANY TORQUING OR TWISTING DURING FIRING? NO. WERE THERE ANY UNUSUAL NOISES HEARD? NO. HOW WAS THE PROCEDURE COMPLETED? RE USEABLE LIGACLIP APPLIER. WAS THERE ANY PATIENT CONSEQUENCE? IF SO, PLEASE EXPLAIN. NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A CLIP IN JAWS AND 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 5 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 DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON USED THE DEVICE AND DISCOVERED THAT THE CLIPS WERE NOT CLOSED COMPLETELY. THE SCRUB NURSE DRY FIRED THE DEVICE 4 TIMES. CLIPS FORMED CORRECTLY. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307470 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1