BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3182918 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02259
    Event Type
    Other
    Date Received
    June 21, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE 23008 WAS ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM).THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE SYSTEM WAS REPAIRED BY REPLACING THE POTENTIOMETER ON THE SUJ AXIS 3. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23008 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT 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 SYSTEM PUTS DA VINCI IN A RECOVERABLE SAFE STATE. THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING DETERMINED THAT AN AXIS MOTOR ENCODER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. ISI HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SITE TO ANSWER ANY ADDITIONAL CLINICAL INFORMATION. IT WOULD HAVE BEEN HELPFUL TO KNOW HOW LONG THE PATIENT WAS UNDER ANESTHESIA PRIOR TO THE ALLEGED ERROR MESSAGE, WHETHER THE SYSTEM WAS CHECKED PRIOR TO THE PROCEDURE AND WHETHER AT THAT TIME THEY NOTICED ANY ERROR MESSAGES, WHAT TYPE OF SURGICAL PROCEDURE THE PATIENT WAS HAVING USING THE DA VINCI S SYSTEM AND THE PATIENT'S STATUS POST-SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE THE SURGICAL STAFF ENCOUNTERED A 22003 SYSTEM ERROR MESSAGE. THE NURSE CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND FOUND THE ERROR MESSAGE WAS POINTING TO THE SETUP JOINT (SUJ3), AND AXIS 3 OF THE ENDOSCOPE CAMERA MANIPULATOR (ECM) ARM. THE TSE REQUESTED THAT THE SITE CYCLE THE ECM SUJ IN SEVERAL DIFFERENT POSITIONS AND THIS RESOLVED THE ERROR MESSAGE. HOWEVER,WHEN THE SITE ATTEMPTED TO RE-DOCK THE PATIENT SIDE CART TO THE PATIENT, THE SYSTEM ERROR 22002 RETURNED. THE SITE EMERGENCY POWER OFF (EPO) THE PATIENT SIDE CART (PSC), AND THE SYSTEM ERROR 2203 APPEARED AFTER EPO. A PORT PLACEMENT HAD ALREADY BEEN PLACED ON THE PATIENT, THE PSC HAD NOT BEEN DOCKED TO THE PATIENT WHEN THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282873 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 SI SYSTEM INSTRUMENTS AND ACCESSORIES