BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2003912 · Received March 1, 2011

    Report

    Report Number
    2955842-2011-00062
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) AND REVIEW OF THE SYSTEM ERROR LOGS DETERMINED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE DOUBLE CAMERA CONTROLLER (DOCO). THE DOCO REFERS TO THE TWO CAMERA CONTROLLER UNITS (CCU) THAT CONTROL THE ACQUISITION AND PROCESSING OF THE IMAGE FROM THE CAMERA. ONE CCU IS ASSIGNED TO THE SURGEON'S RIGHT SIDE IMAGE (RIGHT CCU) AND ONE TO HIS LEFT (LEFT CCU). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED DOCO. THE DOCO WAS RETURNED TO ISI FOR FAILURE ANALYSIS AND THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED AS THE DOCO DID NOT FUNCTION PROPERLY. AS OF MARCH 1, 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 PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED A LOSS OF VIDEO IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE. THE SITE RESEATED AND THEN REPLACED THE CAMERA CABLE, HOWEVER, THE VISION LOSS CONTINUED TO OCCUR. WITH THE ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER, THE SITE RESTARTED THE SYSTEM, HOWEVER, THE VISION LOSS WAS STILL PRESENT. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT INCISIONS HAD BEEN MADE WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P5

    Patients

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