BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3816320 · Received May 16, 2014

    Report

    Report Number
    2955842-2014-03057
    Event Type
    Other
    Date Received
    May 16, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND EVALUATED. THE LEAD NUT WAS FOUND TO BE DAMAGED AND WAS NOT ALLOWING THE CARRIAGE TO TRAVEL ITS FULL RANGE OF MOTION. THE ECM PASSED ALL OTHER FUNCTIONAL TESTS. IN ADDITION, THE LINK 4 CARRIAGE ASSEMBLY WAS ALSO FOUND TO BE DAMAGED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) IN RELATION TO THIS COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION: ROBOTIC CAMERA ARM LOST FUNCTIONALITY OF THE SCOPE AND CAMERA HEAD TWO HOURS INTO THE PROCEDURE. SCOPE WAS REMOVED, THE CASE WAS ABORTED AND COMPLETED LATER THE SAME DAY WHEN A REPLACEMENT ARM WAS OBTAINED BY THE VENDOR.

    Additional Manufacturer Narrative · 1

    THE ECM WAS EVALUATED BY THE FSE AND THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. HOWEVER, THE ECM HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ECM IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI PROSTATECTOMY PROCEDURE AFTER ENCOUNTERING AN ISSUE WITH THE ECM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE INSERTION AXIS ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) WAS NOT HOLDING. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE BECAUSE OF THE REPORTED ECM ISSUE. ON (B)(4) 2014, ISI CONTACTED THE CSR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. HE STATED THAT THE REPORTED ECM ISSUE OCCURRED DURING THE MIDDLE OF THE SURGICAL PROCEDURE AFTER THE SURGICAL STAFF HAD SWAPPED THE ENDOSCOPE. THE DA VINCI SYSTEM HAD BEEN DOCKED TO THE PATIENT FOR APPROXIMATELY 1.5 HOURS BEFORE THE EVENT OCCURRED. THE CSR STATED THAT THE SAME DAY THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE CONFIRMED THE REPORTED ISSUE WITH THE INSERTION AXIS AND REPLACED THE ECM. AFTER REPLACING THE ECM, THE FSE PERFORMED A SYSTEM VERIFICATION AND STAYED AT THE SITE TO OBSERVE THE CONTINUATION OF THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE PATIENT WAS BROUGHT BACK TO SURGERY AND THE DA VINCI PROSTATECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF ANY POST-OPERATIVE COMPLICATIONS OR RECURRENCES OF THE ECM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294148 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other