BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON LIGAMAX CLIP APPLIER

    MDR report key: 13542682 · Received February 15, 2022

    Report

    Report Number
    MW5107474
    Event Type
    Death
    Date Received
    February 15, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 11, 2022
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE FOR A LEFT VIDEO ASSISTED THORACIC SURGERY AND LEFT UPPER LOBECTOMY, CLIP APPLIERS WERE USED TO ISOLATE AND CONTROL PULMONARY BRANCHES. THE LOBECTOMY PROCEEDED WHEN THEY NOTICED BLEEDING FROM THE PULMONARY BRANCHES. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD THAT WAS ACCUMULATING IN THE CHEST CAVITY AND ONCE THEY SUCTIONED IT OUT, THEY WERE ABLE TO SEE THAT THE BLEEDING APPEARED TO BE COMING FROM ONE OF THE SMALL UPPER LOBE PULMONARY ARTERIAL BRANCHES THAT HAD BEEN CLIPPED. THE MEDTRONIC COVIDIEN SIGNIA STAPLER WAS USED (IN CONJUNCTION WITH THE COVIDIEN SIGPSHELL SIGNIA POWER CONTROL SHELL) WAS USED TO CONTROL FOUR OF THE FIVE ARTERIAL BRANCHES. THE PROCEDURE CONTINUED AND THE STAPLER WAS USED IN THE RESECTION OF THE UPPER LOBE AS PLANNED THE LOBECTOMY WAS ALMOST COMPLETED WHEN THE STAPLER WOULD NOT FIRE, A NEW STAPLER HAD TO BE OBTAINED. THE LOBECTOMY WAS COMPLETED AND THE BLEEDING WAS ADDRESSED. FDA SAFETY REPORT IDS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173103 ETHICON LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE GDW ETHICON, INC. EL5ML
    1173104 SIGNIA STAPLING STAPLE, IMPLANTABLE GDW COVIDIEN 24GI00000013

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death