BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2072702 · Received April 29, 2011

    Report

    Report Number
    2955842-2011-00129
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A REMOTE ARM CONTROLLER (RAC) PCA BOARD. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY BOARDS (PCA) WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RAC PCA BOARD. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 25580 IS REPORTED WHEN THE DA VINCI SAFETY SYSTEM DETERMINES A HARDWARE FAULT REACTION LOGIC OCCURRED ON A LOCAL RAC. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. AS OF APRIL 28, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STARTING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED A SYSTEM ERROR CODE 25580. THE PATIENT WAS UNDER ANESTHESIA, AND PORT INCISIONS HAD BEEN PLACED WHEN THE SURGICAL STAFF MADE THE DECISION TO ABORT THE PLANNED SURGICAL 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 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