BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4028969 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05119
    Event Type
    Other
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM 2 WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO DUPLICATE SYSTEM ERROR CODE 23022. THE PSM PASSED MULTIPLE BRAKE TESTS AND THERE WERE NO ISSUES NOTED. AXIS 1 AND AXIS 2 WERE REPLACED AS A PRECAUTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A DA VINCI HYSTERECTOMY PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES DUE TO INSTRUMENT ARTICULATION ISSUES AND THE PATIENT'S ANATOMY. THERE WAS NO ALLEGATION OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 3 WAS NOT ARTICULATING PROPERLY. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SITE RESEATED THE STERILE ADAPTER AND INSTRUMENT; HOWEVER, THE ISSUE WAS NOT RESOLVED. A REPLACEMENT INSTRUMENT WAS INSTALLED; HOWEVER, THE ISSUE PERSISTED. DUE TO THE SYSTEM ISSUE AND PATIENT ANATOMICAL ISSUES, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM REPORTED. REVIEW OF THE SITE'S SYSTEM LOGS FOUND THAT THE SYSTEM ERROR CODE 22008 OCCURRED ON THE REPORTED PSM 3 INDICATING THAT THE INSERTED TOOL WAS NOT ACCEPTED BECAUSE THE CANNULA WAS INSTALLED OR WAS NOT DETECTED. UNRELATED TO THE CUSTOMER REPORTED ISSUE WITH PSM 3 A REVIEW OF THE SYSTEM LOGS ALSO FOUND THAT SYSTEM ERROR CODE 23022 WAS GENERATED ON PSM 2 INDICATING THAT THERE WAS A WEAK HOLDING TORQUE WITH AN AXIS BRAKE. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED AN EVALUATION OF THE SYSTEM. THE FSE WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED FAILURE MODE EXPERIENCED ON PSM 3. FUNCTIONAL TESTING OF PSM 3 FOUND THAT IT FUNCTIONED WITHIN SPECIFICATIONS. DURING PERFORMANCE TESTING ON PSM 2, THE FSE WAS ABLE TO REPRODUCE SYSTEM ERROR CODE 23022. THE SYSTEM WAS REPAIRED BY REPLACING PSM 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507524 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other