BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1172649 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01271
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS - THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE #20008 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTMR. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE #20008 SYSTEM ERROR CODE APPEARED WHEN THE DA VINCI SAFETY SYSTEM DETERMINED THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A "RECOVERABLE SAFE STATE". THE MTMR WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION FOUND THAT ENCODER SENSORS HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERRORS EXPERIENCED BY THE CUSTOMER. AS OF 2008, 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 MYOMECTOMY PROCEDURE THE CUSTOMER EXPERIENCED SYSTEM ERROR CODE #20008. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE EXERCISED THE GRIP ON THE RIGHT MASTER TOOL MANIPULATOR (MTM), HOWEVER, THE FAULTS CONTINUED TO OCCUR. THE TSE INSTRUCTED THE SITE RE-BOOT THE SYSTEM AND DURING HOMING THE ERROR RECURRED. 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DE VINCI SURGICAL SYSTEM| INSRUMENTS