BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1884346 · Received October 27, 2010

    Report

    Report Number
    2955842-2010-00468
    Event Type
    Other
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE RED SYSTEM CABLE. THE RED SYSTEM CABLE CONNECTS THE SURGEON CONSOLE AND THE PATIENT SIDE CART AND PASSES VIDEO, AUDIO, AND DATA DURING SYSTEM OPERATIONS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CABLE. AS OF (B)(4) 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE WAS UNABLE TO POWER ON THE SYSTEM. WITH THE ASSISTANCE OF AN ISI FIELD SERVICE ENGINEER (FSE) AND AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE EMERGENCY POWERED OFF (EPO) THE SYSTEM, REBOOTED THE PSC AND CLEANED THE FIBER OPTIC CABLE; HOWEVER, THE ISSUE PERSISTED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AND TO RESCHEDULE LATER ON THE SAME DAY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU