BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3346012 · Received September 12, 2013

    Report

    Report Number
    2955842-2013-03519
    Event Type
    Other
    Date Received
    September 12, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 13, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE SYSTEM ERROR CODES 23008 AND 212 EXPERIENCED BY THE SITE WERE ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) AND MULTIPLE SERVO DRIVER (MSD). THE MTM 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 CONTAINS TWO MSD PCA BOARDS WHICH PROVIDE DRIVE CURRENT TO THE SERVO MOTORS ASSOCIATED WITH EACH DEGREE OF FREEDOM FOR EACH SYSTEM ARM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTM AND MSD. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODES) 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. SYSTEM ERROR CODE 212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUTS DA VINCI S IN A RECOVERABLE SAFE STATE. THE MTML AND MSD BOARD WERE RETURNED TO ISI FOR EVALUATION. ENGINEERING WAS ABLE TO DUPLICATE THE SYSTEM ERROR CODE 212 ON AXIS 4 OF THE MTML DURING A HARNESS WIGGLE TEST. THE MAIN CABLE HARNESS WAS REPLACED TO REPAIR THE MTML. FUNCTIONAL TESTING OF THE MSD BOARD INSTALLED ON AN ISI IN-HOUSE TEST SYSTEM FOUND THAT IT FUNCTIONED WITHIN SPECIFICATION AND THERE WERE NO SYSTEM ERROR CODES GENERATED. AS OF SEPTEMBER 10, 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING RECURRING SYSTEM ERROR CODES WITH THE DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 23008. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER, THE SITE EXERCISED THE LEFT MASTER TOOL MANIPULATOR (MTML) TO RECOVER FROM THE FAULT; HOWEVER, THE ISSUE RECURRED. THE SITE THEN POWERED OFF THE SYSTEM, THE BREAKER WAS RESET AND PERFORMED AN EMERGENCY POWER OFF (EPO) OF THE SURGEON SIDE CART (SSC); HOWEVER, WHILE THE SYSTEM WAS HOMING, SYSTEM ERROR CODE 212 OCCURRED. ADDITIONAL TROUBLESHOOTING TECHNIQUES WERE PERFORMED TO RESOLVE THE ISSUE; HOWEVER, THE ISSUE PERSISTED. THE SURGEON MADE THE DECISION TO COVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION. THE INITIAL REPORTER INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. HE INDICATED THAT THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND TO THE BEST OF HIS KNOWLEDGE, THE PATIENT DID NOT EXPERIENCE ANY POST-SURGICAL COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458700 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI S SURG SYS INSTRMNTS, ACCESSORIES AND ES