BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP APPLIER UNKNOWN PRODUCT

    MDR report key: 20905013 · Received December 11, 2024

    Report

    Report Number
    3005075853-2024-09408
    Event Type
    Death
    Date Received
    December 11, 2024
    Date of Event
    November 1, 2023
    Report Date
    December 11, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/11/2024. B3: UNKNOWN, ASSUMED FIRST DAY OF MONTH THAT COMPLAINT WAS REPORTED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: "PROCEDURE: LOBECTOMY. TITANIUM CLIP HAS BEEN PLACED ON PULMONARY ARTERY. THE OUTGOING BRANCHES WERE SUPPLIED WITH HARMONIC. PROBABLY IN MAXIMUM MODE. THE VESSEL WAS INITIALLY CLOSED. AFTER THE OPERATION, THE PATIENT SUDDENLY BLED HEAVILY FROM THE DRAINAGE AND COLLAPSED. A REANIMATION HAS BEEN STARTED. THE CHEST HAS BEEN REOPENED. THE HOLE WAS FOUND AND TEMPORARILY CLOSED. THE PATIENT WAS STABILIZED WITH TRANSFUSIONS AND THE BLEEDING WAS STOPPED. THE PATIENT DIED AFTER 2 WEEKS OF TREATMENT IN THE WARD." "SHORT ANSWER FROM SALES REP: WAS IT POWERED OR MANUAL? IT WASN´T A STAPLER. IT WAS A TITANIUM CLIP. CAN YOU PLEASE CONFIRM THAT IT WAS A TITANIUM CLIP THAT BECAME LOOSE OR WAS IT A TITANIUM STAPLE LINE THAT CAME LOOSE? A TITANIUM CLIP. IS THE SURGEON INTERESTED IN A CONFERENCE CALL WITH ETHICON MEDICAL AND ENGINEERING TEAM? I WILL OFFER HIM THAT OPPORTUNITY".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A CLIP HAS COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732467 LIGACLIP APPLIER UNKNOWN PRODUCT CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death