BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2013395 · Received March 10, 2011

    Report

    Report Number
    2955842-2011-00070
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 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 CORE POWER DISTRIBUTION (IPD) BOARD. THE IPD IS A PCA (PRINTED CIRCUIT ASSEMBLY) BOARD THAT CONVERTS THE INCOMING ELECTRICAL VOLTAGE TO THE APPROPRIATE LEVELS TO POWER THE OTHER CIRCUIT BOARDS AND REGULATES THE CURRENT SUPPLIED TO THEM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED IPD PCA BOARD. THE IPD PCA BOARD WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS ABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT AND FOUND A DEFECTIVE MODULE ON THE IPD PCA BOARD. AS OF (B)(6) 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 WAS UNABLE TO GET THE SYSTEM TO POWER ON. THE SITE RECONNECTED ALL AND CHANGED ALL POWER OUTLET CONNECTIONS, HOWEVER THE SYSTEM CONTINUED TO NOT GAIN POWER. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER THE SITE RESET THE MAIN SYSTEM BREAKER, HOWEVER, THE SYSTEM CONTINUED TO NOT POWER ON. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AND RESCHEDULE FOR A LATER DATE. 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 A6.0P5

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other DA VINCI SI SYS, INSTRUMENTS AND ACCESSORIES