BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOWRIST

    MDR report key: 4534574 · Received January 27, 2015

    Report

    Report Number
    4534574
    Date Received
    January 27, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 27, 2015
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INITIALLY THERE WAS NO OUTPUT WHEN THE SURGEON ACTIVATED THE DEVICE. THEY DISCONNECTED AND RECONNECTED THE TOOL AND MACHINE CONNECTOR AND STILL NO OUTPUT WHEN ACTIVATED. THEY DISCONNECTED AND RECONNECTED A 2ND TIME AND WHEN THE SURGEON ACTIVATED THE ELECTROSURGICAL UNIT (ESU), THE CABLE BLEW APART AND THERE WAS A FIRE AT THE CONNECTOR. THE SURGEON WAS USING DAVINCI MONOPOLAR SCISSORS CONNECTED TO THE ESU VIA AN INTEGRA LIFE SCIENCES JARIT ACTIVE CABLE PART 600-290. INITIAL INSPECTION OF DEVICE SHOWS OBVIOUS BURNING OF THE CABLE AND CABLE IS IN 2 PIECES BUT NO OBVIOUS ISSUES WITH THE ESU DEVICE ITSELF. ESU DEVICE PASSED ALL BIOMED TESTING WITH NO FAILURES. THE MANUFACTURER REQUESTED THE UNIT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60810 ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. * *
    61464 FORCE FX ELECTROSURGICAL GEI COVIDIEN * *
    61465 JARIT ELECTROSURGICAL CABLE GEI INTEGRA LIFESCIENCES CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR