BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA SMALL APPLIER

    MDR report key: 8367899 · Received February 25, 2019

    Report

    Report Number
    3005075853-2019-16853
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    UDI-DI
    10705036002499
    PMA / PMN Number
    K820837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PC-000385523 (B)(4). BATCH # R93U4C, R93699. LOT # R40G12. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE MCS20 DEVICE A 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 13 CLIPS AS INTENDED. THE ANALYSIS RESULTS FOUND THAT FOUR MCS20 DEVICES B,C,D,E WERE RETURNED INSIDE THE ORIGINAL PACKAGING AND 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 20 CLIPS AS INTENDED. AS THE DEVICES WERE 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 REPORTED COMPLAINT COULD NOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER R40G12 , AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER R93U4C, R93699, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER R40P1M, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY, THE CLIPS WERE FALLING OFF THE TISSUE AND SCISSORING WHEN DEPLOYED. THERE WAS ALSO AN AUDIBLE TACTILE FEEDBACK SOUND, WHEN THE CLIPS WERE DEPLOYED. THE DOCTOR COMPLETED THE PROCEDURE USING CLIP APPLIERS FROM A DIFFERENT LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162069 LIGACLIP*MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. R40P1M 10705036002499

    Patients

    Seq Age Sex Outcome Treatment
    1