BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3348332 · Received September 13, 2013

    Report

    Report Number
    2955842-2013-03571
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE. THE FSE TESTED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH PSM3. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. ACCORDING TO THE SYSTEM LOGS, THE SURGICAL STAFF ENCOUNTERED MULTIPLE SYSTEM ERROR 31009 AND 31011 CODES POINTING TO PSM3 DURING THE FIRST 20 MINUTES OF THE SURGICAL PROCEDURE. AN ERROR 31009 INDICATES THAT A TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. AN ERROR 31011 INDICATES AN ATTEMPT TO WRITE TO A TOOL'S DALLAS CHIP (NON-VOLATILE MEMORY) FAILED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER EXPERIENCING ENGAGEMENT ISSUES ON PSM3.

    Additional Manufacturer Narrative · 1

    ON 02/10/2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE SPOKE TO THE SURGEON AFTER THE EVENT OCCURRED AND THERE WERE NO REPORTS OF ANY OPERATIVE COMPLICATIONS RELATED TO THE PATIENT. HE WAS INFORMED BY THE SURGEON THAT THE OPEN SURGERY WAS COMPLETED SUCCESSFULLY. ON 02/10/2014, ISI ALSO CONTACTED THE SITE'S RISK MANAGER. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT INVOLVED WITH THIS COMPLAINT. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON MADE THE DECISION TO CONVERT TO A LAPAROTOMY DUE TO THE EXTENT OF FIBROID DEPTH INVOLVEMENT. THE SURGEON FELT AS THOUGH IT WOULD BE SAFER TO PROCEED WITH A LAPAROTOMY DUE TO THE EXTENT OF THE FIBROID. THE RISK MANAGER STATED THAT THE REASON TO CONVERT TO OPEN SURGICAL TECHNIQUES WAS NOT DUE TO A MALFUNCTION OF THE DA VINCI SYSTEM. THE RISK MANAGER INDICATED THAT THE LAPAROTOMY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT HOME THE SAME DAY. NO POST-OP COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED ENGAGEMENT ISSUES WITH PATIENT SIDE MANIPULATOR 3 (PSM3). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE SURGEON REPORTEDLY EXPERIENCED CONTROL ISSUES ON PSM3. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) FOR ASSISTANCE AFTER THE SURGEON HAD ALREADY CONVERTED THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES. IN TURN, THE CSR CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE ISSUE WITH PSM3. ACCORDING TO THE TSE, THE SITE INDICATED THAT THEY HAD INITIALLY GOTTEN A LOCKED MESSAGE THAT PROHIBITED THE SURGICAL STAFF FROM USING THE DA VINCI SI SURGICAL SYSTEM. HOWEVER, THE SURGICAL STAFF WAS ABLE TO RECOVER FROM THE FAULT AND PROCEED WITH THE CASE. THE TSE RECOMMENDED FOR AN ISI FIELD SERVICE ENGINEER (FSE) TO CHECK INSTRUMENT ENGAGEMENT ON PSM3 AND TO TEST DRIVE THE SYSTEM. ON (B)(4) 2013, AN ISI FSE PERFORMED A FIELD EVALUATION AT THE SITE BUT WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH PSM3. THE FSE INSTALLED INSTRUMENTS ON ALL OF THE PSM'S AND TEST DROVE THE SYSTEM. THE FSE NOTED THAT HE COULD NOT REPRODUCE THE REPORTED ISSUE WITH PSM3 AND THE SYSTEM WAS WORKING PROPERLY. THE FSE WAS UNABLE TO PERFORM SYSTEM VERIFICATION DURING THE FIELD EVALUATION SINCE THE SITE WAS SETTING UP FOR THE NEXT DA VINCI SURGICAL PROCEDURE. THE SURGICAL STAFF INFORMED THE FSE THAT THE SYSTEM WAS WORKING PROPERLY DURING A FOLLOW UP CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461051 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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