BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1791902 · Received July 30, 2010

    Report

    Report Number
    2955842-2010-00350
    Event Type
    Other
    Date Received
    July 30, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE #297 WAS ASSOCIATED WITH THE EMBEDDED SERIALIZER SETUP JOINT (ESSJ) PRINTED CIRCUIT ASSEMBLY. THE ESSJ MONITORS THE PRIMARY AND SECONDARY JOINT POSITION SENSORS (POTENTIOMETERS) FOR EACH OF THE JOINTS OF THE SETUP JOINT ARM. THE SETUP JOINT ARM IS THE PASSIVE PORTION OF THE PATIENT SIDE ARM THAT AIDS IN CORRECTLY POSITIONING THE ACTIVE, MOTORIZED PATIENT SIDE ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ESSJ. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE #297 INDICATES THAT THE SYSTEM DETECTED THAT AN ELECTRONIC COMPONENT WAS REPORTING AN INCORRECT CONFIGURATION. SYSTEM ERROR CODE #297 THEN PUTS THE DA VINCI S SYSTEM INTO A NON-RECOVERABLE "SAFE STATE." THE ESSJ WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DISCOVERED THAT THE BALL GRID ARRAY COMPONENT OF THE ESSJ HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. 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 DURING A DA VINCI S SURGICAL PROCEDURE, NON-RECOVERABLE SYSTEM ERROR CODE #297 OCCURRED. THE SURGICAL STAFF POWERED DOWN THE SYSTEM, PERFORMED AN EMERGENCY POWER OFF, AND RESET THE BREAKER MULTIPLE TIMES, HOWEVER, ERROR CODE #297 CONTINUED TO RECUR. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. 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