BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2072858 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01785
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 6, 2011
    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
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCKOUT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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, AND FORMED THE REMAINING CLIPS AS INTENDED. HOWEVER, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE HANDLE LOCKOUT POSTS WERE FOUND TO BE BROKEN WHICH DENOTES THAT THE LOCKOUT HAD BEEN FIRED THROUGH AS A RESULTS OF A LOCKOUT PREMATURE. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND CONDITION. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE MALFORMED AND SLIPPED OUT OF THE JAW. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4PT0R

    Patients

    Seq Age Sex Outcome Treatment
    1