BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE CLIP APPLIER

    MDR report key: 2001385 · Received February 25, 2011

    Report

    Report Number
    3005075853-2011-00745
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 30, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY CLIP FORMATION ISSUES. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING REQUIREMENTS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER'S SHAFT IS BENT. THE CLIPS ARE NOT BEING CLOSED PROPERLY CLOSED ON THE VESSELS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1