BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 6077501 · Received November 3, 2016

    Report

    Report Number
    3005075853-2016-06294
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    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: WAS THE DEVICE EVER ABLE TO BE OPENED OFF OF THE CYSTIC DUCT DURING THE PROCEDURE? YES, BUT WITH SOME FORCE TO UNLOCK THE JAWS. IF SO, HOW WAS THE DEVICE OPENED OR REMOVED FROM TISSUE? AS ABOVE. PLEASE CLARIFY AS YOU SAID YOU WILL BE SENDING MISFIRED CLIPS? A COUPLE OF THE MISFIRED CLIPS WERE REMOVED FROM THE PATIENT AND KEPT, I WILL INCLUDE THESE IN THE BOX WITH THE DEVICE. DOES MISFIRED MEAN THE CLIPS FIRE SIDEWAYS? NO, THEY DID NOT FULLY CLOSE DOES MISFIRED MEAN THE CLIPS DROPPED OR EJECTED FROM THE JAWS OF THE DEVICE? NO, AS ABOVE. DOES MISFIRED MEAN THE CLIPS WERE SCISSORED OR MALFORMED WHEN FIRED? NO, AS ABOVE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS; UPON VISUAL INSPECTION, 2 CLIPS WERE NOTED TO BE JAMMED INSIDE THE SHAFT. THE CLIPS WERE REMOVED IN ORDER TO PERFORM FUNCTIONAL TESTING. IN ADDITION, 3 CONFORMING CLIPS AND 1 MALFORMED CLIP WERE RETURNED FOR ANALYSIS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, IT WAS NOTED THAT THE CLIPS WERE NOT FED INTO THE JAWS IN THE NEXT ACTUATIONS OF THE TRIGGER. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE FEED LINK WAS NOTED BROKEN CAUSING THE FEEDING ISSUES AND 1 CLIP WAS FOUND INSIDE THE CLIP TRACK. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, DEVICE CLAMPED ONTO CYSTIC DUCT AND WOULDN'T OPEN. DEVICE CLIPPED NORMALLY ON FIRST APPLICATION BUT THEN LOCKED ON SECOND AND CLAMPED SHUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728356 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1