BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 6520552 · Received April 25, 2017

    Report

    Report Number
    3005075853-2017-02223
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 20, 2017
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE NO DAMAGE. IN ADDITION, A TYVEK FROM OTHER DEVICE WAS RETURNED FOR ANALYSIS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED, RETAINED AND FORMED THE REMAINING 14 CLIPS AS INTENDED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, NO ANOMALIES WERE FOUND. AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC DONOR NEPHRECTOMY PROCEDURE, THE SURGEON FIRED FIRST TWO CLIPS ON A VESSEL, AND THE ENDS OF THE CLIP APPEARED TO SLIGHTLY SCISSOR WHEN THE CLIPS CLOSED. THE THIRD CLIP WAS SLIGHTLY CROOKED WHEN IT FED INTO THE APPLIER. HE REMOVED THE CLIP APPLIER AND FIRED IN THE AIR TO EJECT THE THIRD CLIP AND LOAD ANOTHER. THE FOURTH CLIP DROPPED OUT OF THE APPLIER. HE DECIDED TO USE A NEW APPLIER AND IT WORKED WITHOUT ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299140 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA N4M79P

    Patients

    Seq Age Sex Outcome Treatment
    1