BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2232012 · Received September 1, 2011

    Report

    Report Number
    2955842-2011-00285
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM POWER ISSUE WAS ASSOCIATED THE SET UP JOINT (SUJ) WIRING HARNESS. THE SUJ WIRE HARNESS ASSEMBLY IS A SET OF ELECTRICAL WIRES INSIDE THE SETUP JOINT WHICH TRANSMITS POWER, CONTROL AND SENSOR SIGNALS BETWEEN CIRCUIT BOARDS IN THE SLAVE ARMS AND THE BASE OF THE PATIENT SIDE CART. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED IPD PCA BOARD. AS OF (B)(4) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SITE EXPERIENCE A SYSTEM ERROR CODE STATING THAT THE PATIENT SIDE CART (PSC) WAS NOT CONNECTED. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE APPLIED EMERGENCY POWER OFF (EPO) TO THE PSC AND SWAPPED THE BLUE FIBER CABLE FROM THE SURGEON SIDE CART (SSC) AND THE PSC WITH NO CHANGE. THE SITE THEN EPO'D THE SYSTEM AGAIN AND CYCLED THE BREAKER ON THE VISION SIDE CART WITH NO CHANGE. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYS, INSTRUMENTS AND ACCESSORIES