BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4182892 · Received October 17, 2014

    Report

    Report Number
    2955842-2014-05506
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. INVESTIGATION WAS UNABLE TO REPLICATE THE NON-INTUITIVE MOTION EXPERIENCED BY THE SITE. HOWEVER, THE PSM FAILED A WEIGHTED BRAKE DROP TEST. THE PSM, SYSTEM ERROR CODE 23022 WAS GENERATED AND FOUND TO BE ASSOCIATED WITH THE PSM'S AXIS 2 BRAKE. AXIS 2 WAS REPLACED TO REPAIR THE PSM. AXIS 1 WAS REPLACED AS A PRECAUTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND IN THE DA VINCI SI SYSTEM LOGS AND NO PATIENT INVOLVEMENT OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE ENDOWRIST INSTRUMENT INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) ARM 3 ON THE PATIENT SIDE CART (PSC) WAS MOVING BACKWARDS. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE. WITH THE ASSISTANCE OF THE TECHNICAL SUPPORT ENGINEER (TSE) THE SITE POWER CYCLED THE SYSTEM, RESEATED THE INSTALLED INSTRUMENT; HOWEVER, THE ISSUE PERSISTED. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT THREE ADVISORY LOGS OCCURRED: 31009, 282 AND 30. NONE OF THESE LOGS ARE VISIBLE TO THE USER. ADVISORY LOG 31009 OCCURRED ABOUT 1 MINUTE AFTER THE PROCEDURE WAS STARTED INDICATING THAT THE SYSTEM COULD NOT DETECT ONE OR MORE OF THE REDUNDANT SENSORS THAT ARE USED TO SENSE TOOL PRESENCE. THIS LOG INDICATES THAT THERE IS A CONNECTION ISSUE BETWEEN PSM ARM, STERILE ADAPTER AND ENDOWRIST INSTRUMENT. SIMILARLY, ADVISORY LOG 282 INDICATES THAT AN INSTRUMENT COULD NOT BE VALIDATED BECAUSE SENSORS WERE NOT DETECTED. ERROR CODE 30 INDICATES THAT THE HARDWARE DETECTED SOME INTERMITTENT COMMUNICATION ISSUE WITH THE SYSTEM WHICH MAY BE DUE TO FAULTY HARDWARE OR HARNESSES. A FIELD INVESTIGATION PERFORMED BY AN ISI FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2014, CONCLUDED THAT THE ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE PSM. THE AFFECTED PSM WAS REPLACED TO REPAIR THE SYSTEM. THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, THE SURGEON DISABLED PSM 3 AND THE PLANNED PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE DA VINCI SURGICAL SYSTEM. THE ROBOTICS COORDINATOR INDICATED THAT NO PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661331 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1