BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1616224 · Received February 25, 2010

    Report

    Report Number
    2955842-2010-00068
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    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 FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODES 41049 AND 23017 WERE ASSOCIATED WITH THE REMOTE ARM CONTROLLER (RAC) AND/OR THE MASTER TOOL MANIPULATOR (MTM) GIMBAL. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY (PCA) BOARDS WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM ARM, CONSISTING OF THE LINKS ASSOCIATED WITH THE FIVE AXES OF MOTION CLOSEST TO THE SURGEON'S HAND. THESE AXES MEASURE THE ORIENTATION OF THE MTM HANDLE AND THE MTM GRIP ANGLE. THE GIMBAL IS SEPARATED FROM THE REST OF THE MTM BY REMOVING THE PLATFORM LINK FROM THE FOREARM LINK. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RAC AND MTM GIMBAL. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE 41049 SYSTEM ERROR CODE APPEARS WHEN THE DA VINCI SI SAFETY SYSTEM (SUPERVISOR) DETECTED AN INTERNAL LOGIC ERROR, THUS PUTTING THE SYSTEM IN A RECOVERABLE SAFE STATE. SYSTEM ERROR CODE 23017 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT A MOTOR DID NOT RESPOND AS EXPECTED AND THE MEASURED MOTION DID NOT MATCH THE INTERNAL SIMULATION OF THE MOTOR. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE RAC AND MTM GIMBAL WERE RETURNED TO ISI FOR EVALUATION. ENGINEERING DETERMINED THAT THE RAC DRIVE MODULE WAS DEFECTIVE, RESULTING IN THE CUSTOMER EXPERIENCED SYSTEM ERROR CODES. THE MTM GIMBAL WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATIONS WITH NO DEFECTS. AS OF FEBRUARY 24, 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 SI SURGICAL PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 41049 WHILE CLUTCHING A PATIENT SIDE MANIPULATOR (PSM) ARM. THE SYSTEM WAS ALSO FAULTING WITH MULTIPLE OCCURRENCES OF SYSTEM ERROR CODE 23017. THE SURGICAL STAFF MADE THE DECISION TO NOT TROUBLESHOOT THE SYSTEM ERRORS AND ABORTED THE PROCEDURE AFTER ANESTHESIA HAD BEEN ADMINISTERED AND PORTS PLACED. NO PATIENT HARM 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 A6.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI INSTRUMENTS, ACCESSORIES, AND ESU