BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2123830 · Received June 14, 2011

    Report

    Report Number
    2955842-2011-00176
    Event Type
    Other
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    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 ISI FIELD SERVICE ENGINEERING FOUND THE POWER ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE SURGEON SIDE CONSOLE PRIMARY POWER SUPPLY (PPS2). THE PPS2 IS A 230V POWER SUPPLY WITH BATTERY BACKUP. THE SYSTEM WAS REPAIRED BY REPLACING THE PPS2 AND THE POWER SUPPLY FAN AND THE BATTERY PACK MODULE AS A PRECAUTION. 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 DURING A DA VINCI S LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) EXPERIENCED A POWER LOSS. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE RESTARTED THE SYSTEM, HOWEVER, AFTER HOMING THE SSC CONTINUED TO RUN OFF OF THE BATTERY BACK-UP SYSTEM. THE SITE TRIED MULTIPLE OUTLETS IN THE OPERATING ROOM, HOWEVER, THE SSC CONTINUED TO RUN FROM THE BATTERY BACK-UP SYSTEM. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH 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 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 AND ACCESSORIES