BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 2881469 · Received December 12, 2012

    Report

    Report Number
    MW5028218
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INTUITIVE
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I WAS USING THE DAVINCI SYSTEM FOR A HYSTERECTOMY ON A (B)(6). THE PRECISE BIPOLAR INSTRUMENT WAS INSERTED AND WHEN I GRASPED TISSUE THE CURRENT ACTIVATED WITHOUT THE FOOT PEDAL BEING PRESSED. THE AUDIBLE POWER SOUND WAS HEARD AND THE GRASPED TISSUE WHICH FORTUNATELY WAS A FALLOPIAN TUBE WAS CAUTERIZED. THE ENTIRE CREW IN THE OPERATING ROOM WITNESSED THIS EVENT. I THEN GRASPED THE UTERUS IN SEVERAL LOCATIONS AND THE INSTRUMENT AGAIN TRANSMITTED ENERGY WITH THE GRASPING OF TISSUE WITHOUT USE OF THE FOOT PEDAL. THE DEVICE WAS REMOVED AND THE PK DEVICE INSERTED, TESTED AND THE CASE PROCEEDED WITHOUT INCIDENT. EXAM OF THE BOWEL AND SURROUNDING TISSUE DISCLOSED NO INJURY AND THE PT WAS DISCHARGED THE NEXT MORNING. THIS ONLY OCCURRED 2 DAYS AGO HOWEVER SO POTENTIAL FOR DELAYED INJURY STILL EXISTS. A SIMILAR EVENT HAD OCCURRED 2 MONTHS AGO USING A FENESTRATED BIPOLAR DEVICE ON THE SAME SYSTEM AND GENERATOR WHERE UPON INSERTION OF THE INSTRUMENT ENERGY WAS IMMEDIATELY DELIVERED PRIOR TO FOOT PEDAL ACTIVATION. THE DEVICE WAS DISCONNECTED, REINSERTED AND THE PROBLEM DID NOT RECUR ON THE SECOND ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM SURGICAL SYSTEM NAY INTUITIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O