BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA SMALL APPLIER

    MDR report key: 8264452 · Received January 21, 2019

    Report

    Report Number
    3005075853-2019-16076
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 4, 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

    (B)(4). BATCH # R94R0J . DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT 21 MCS20 STERILE DEVICES WERE TO BE RETURNED ALONG WITH 1 COMPLAINT DEVICE WITH NO DAMAGE IN THE EXTERNAL COMPONENTS; UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE (A) A CLIP WAS NOTED TO BE JAMMED BETWEEN THE JAWS AND THE CARTRIDGE COVER TABS. THE CLIP WAS REMOVED IN ORDER TO PERFORM FUNCTIONAL TESTING. IN ADDITION, THE TYVEK WAS RETURNED ALONG WITH THE INSTRUMENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 11 CONFORMING CLIPS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. THE REMAINING 21 DEVICES(B,C,D,E,F,G,H,I,J,K,L,M,N,O,P,Q,R,S,T,U,V) WERE TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICES WERE CYCLED AND IT FED AND FORMED THE REMAINING 20 CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE CLIP JAMMING IN THE DEVICE (A). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE R94R0J NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE 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 THE MCS20 CLIP APPLIER IS ¿JAMMING¿, NOT LOADING A CLIP AND/ HANDLE NOT OPENING ONCE CLIP IS LOADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58261 LIGACLIP*MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. R41672 10705036002499

    Patients

    Seq Age Sex Outcome Treatment
    1