BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP*MCA LARGE APPLIER

    MDR report key: 14950482 · Received July 7, 2022

    Report

    Report Number
    3005075853-2022-04424
    Event Type
    Death
    Date Received
    July 7, 2022
    Date of Event
    March 9, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    UDI-DI
    10705036002468
    PMA / PMN Number
    K820837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. THE MANUFACTURING RECORD EVALUATION IS PENDING FOR THE FINISHED DEVICE LOT NUMBER PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WAS THERE ANY DIFFICULTY WITH THE DEVICE INTRAOPERATIVELY? WHAT WAS THE ESTIMATED BLOOD LOSS? WAS THERE ANY DIFFICULTY WITH CLIP APPLICATION? WAS THERE ANY CLIP FORMATION ISSUE DURING THE SURGICAL PROCEDURE? CAN YOU FURTHER DESCRIBE THE SHAPE OF THE CLIPS? IS THE SURGEON INTERESTED IN SPEAKING WITH ETHICON MEDICAL AND ENGINEERING STAFF? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SEE ATTACHED MEDWATCH FORM # 5110542.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986149 LIGACLIP*MCA LARGE APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. MCL20 175A96 10705036002468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D