BEUDAMED
    FDA Adverse Event Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER

    MDR report key: 6190521 · Received December 20, 2016

    Report

    Report Number
    3005075853-2016-07185
    Date Received
    December 20, 2016
    Report Date
    December 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE MSM20 DEVICE WAS RETURNED WITH A CLIP IN THE JAWS. 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 9 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). 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 AN UNKNOWN PROCEDURE, THE CLIP WAS NOT RELEASED. THE EXERTED PRESSURE HAS CUT THE VESSEL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840482 LIGACLIP MCA MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA N4LT42

    Patients

    Seq Age Sex Outcome Treatment
    1 Other