BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3781691 · Received April 30, 2014

    Report

    Report Number
    2955842-2014-02703
    Event Type
    Other
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD INVESTIGATION WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE). THE FSE WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE FSE WAS UNABLE TO TEST THE SITE'S DA VINCI SURGICAL SYSTEM USING THE SAME INSTRUMENTS USED DURING THE SURGICAL PROCEDURE, AS THEY WERE NOT AVAILABLE AT THE TIME OF HIS INVESTIGATION. HOWEVER, FUNCTIONAL TESTING OF THE SITE'S SYSTEM BY THE FSE USING TEST ENDOWRIST INSTRUMENTS, A TEST DRAPE AND A TEST CANNULA FOUND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO COMPLETE A DA VINCI SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES DUE TO ENGAGEMENT ISSUES THAT OCCURRED DURING THE SURGICAL PROCEDURE AND ISSUES WITH THE PATIENT'S ANATOMY. AS OF (B)(6) 2014, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE FAILURE MODE AT THIS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI MYOMECTOMY PROCEDURE, THE SITE EXPERIENCED INTERMITTENT ENGAGEMENT ISSUES AFTER INSTALLING THE ENDOWRIST INSTRUMENTS ONTO PATIENT SIDE MANIPULATOR (PSM) 2. THE SITE EXCHANGED MULTIPLE INSTRUMENTS AND RESEATED THE STERILE ADAPTERS; HOWEVER, THE ISSUE PERSISTED. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TECHNICAL SUPPORT ENGINEER FOUND THAT THE SITE EXPERIENCED SEVERAL INSTANCES OF SYSTEM ERROR CODE 31009 INDICATING THAT THERE WAS AN INTERMITTENT CONNECTION ISSUE BETWEEN THE PSM ARM AND/OR THE STERILE ADAPTER. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC), THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE STERILE ADAPTER IS PART OF THE PSM DRAPE AND PROVIDES THE POINT OF CONNECTION BETWEEN THE ENDOWRIST INSTRUMENT AT THE PSM ARM. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THE INCIDENT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE CASE WAS DIFFICULT DUE TO THE PATIENT'S ANATOMY AND THAT THE SURGEON'S DECISION TO USE OPEN SURGICAL TECHNIQUES WAS IN PART DUE TO THE INTERMITTENT ENGAGEMENT ISSUES AND THE PATIENT'S ANATOMY. THE CSR REVIEWED THE STEPS WITH THE SURGICAL STAFF REGARDING THE PROCESS ON ENDOWRIST INSTRUMENTATION AND DRAPE INSTALLATION AND ENGAGEMENT. ACCORDING TO THE CSR, THERE WERE NO ISSUES IDENTIFIED DURING THE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259958 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other