BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S PERMANENT CAUTERY HOOK

    MDR report key: 5441986 · Received February 11, 2016

    Report

    Report Number
    MW5060222
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 11, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ELECTIVE ROBOTIC CHOLECYSTECTOMY, WITH FIREFLY ICG CHOLANGIOGRAM FOR SYMPTOMATIC CHOLELITHIASIS. WHILE REMOVING THE GALLBLADDER, THE SURGEON NOTED ARCING OF THE HOOK CAUTERY TOWARD THE LIVER, WITH UNINTENTIONAL CAUTERIZING OF THE LEVER EDGE. NO THERMAL INJURIES NOTED OTHERWISE. THE SIDE OF ROBOTIC HOOK WAS CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89172 DA VINCI S PERMANENT CAUTERY HOOK HOOK CAUTERY NAY CARDINAL HEALTH 420183 M10150126-10

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR