BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 6067661 · Received October 31, 2016

    Report

    Report Number
    3005075853-2016-06195
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N92085: THE ANALYSIS RESULTS FOUND THAT THE MCM20 DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED AND IT FED AND FORMED THE REMAINING 14 CLIPS AS INTENDED. AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL, IT COULD NOT BE DETERMINED 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). DATE SENT: 10/31/2016. BATCH # UNK. 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 RECTOSIGMOID RESECTION PROCEDURE, AFTER CLIPPING THE DESIRED STRUCTURE THE CLIPS CAME LOOSE AND NEW CLIPS HAD TO BE APPLIED. A NEW MCM20 WAS USED AND THE PROCEDURE WAS FINISHED WITHOUT ANY FURTHER ISSUES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717146 CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA N4LT4Z

    Patients

    Seq Age Sex Outcome Treatment
    1