BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2972455 · Received February 21, 2013

    Report

    Report Number
    2955842-2013-00587
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE SURGEON: THE REPORTED DA VINCI SI SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2013. THE REPORTED VISION ISSUE WITH THE DA VINCI SI SYSTEM OCCURRED APPROXIMATELY AN HOUR AFTER THE SURGICAL PROCEDURE HAD BEGUN. DUE TO THE ALLEGED VISION ISSUE, THE SURGEON MADE THE DECISION TO FINISH THE SURGICAL PROCEDURE LAPAROSCOPICALLY USING THE SAME INCISION PORTS AND THE PATIENT DID NOT SUSTAIN ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE SURGEON, THE DA VINCI SI CARDIAC-THORACIC PROCEDURE WAS NOT CONVERTED TO OPEN SURGICAL TECHNIQUES AS REPORTED IN THE INITIAL REPORT OF THIS COMPLAINT. THE SURGEON INDICATED THAT THE PATIENT WAS DOING FINE AND HAD NOT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS. THE SURGEON DID NOT KNOW WHAT CAUSED OR CONTRIBUTED TO THE ALLEGED VISION ISSUE OF THE DA VINCI SI SYSTEM. THE SURGEON ALSO DENIED THAT THERE WERE ANY ISSUES DURING THE 3-D CALIBRATION OF THE ENDOSCOPE. AN ISI FIELD SERVICE ENGINEER (FSE) EVALUATED THE DA VINCI SI SYSTEM USING THE SAME ENDOSCOPE THAT WAS INVOLVED WITH THE ALLEGED ISSUE AND PERFORMED A SYSTEM VERIFICATION THAT WAS FOUND TO BE WITHIN SPECIFICATION. THE FSE INDICATED THAT THE ENDOSCOPE WAS NOT DEFECTIVE AND WILL NOT BE RETURNED TO ISI FOR INVESTIGATION. THE SURGEON INDICATED THAT THE PATIENT WAS (B)(6). BASED ON THE FOLLOW-UP INFORMATION, THIS COMPLAINT IS BEING RECLASSIFIED AS A NON-REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THERE IS NO EVIDENCE THAT THE PATIENT EXPERIENCED A SERIOUS INJURY BECAUSE OF THE REPORTED EVENT. IN ADDITION, A RECURRENCE OF THE ALLEGED VISION ISSUE WITH THE HRSV IS NOT EXPECTED TO BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE VISION ISSUE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE SITE'S DA VINCI SURGICAL SYSTEM FOUND THAT THE SYSTEM FUNCTIONED WITH IN SPECIFICATIONS. ON (B)(4) 2013, ISI RECEIVED ADDITIONAL INFORMATION FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS EVENT. THE CSR INDICATED THAT THE SITE DID NOT CONTACT ISI FOR TECHNICAL SUPPORT ASSISTANCE TO RESOLVE THE VISION ISSUE. THE CSR INDICATED THAT THE OR NURSE INDICATED TO HER THAT THE ILLUMINATOR FAILED INTRAOPERATIVELY AND THAT WHEN THE ENDOSCOPE WAS OUTSIDE OF THE PATIENT, THE FLOW OF LIGHT THROUGH THE OPTIC WAS OBSERVED. PER THE CSR, THE OR NURSE INDICATED THAT AFTER INTRODUCING THE ENDOSCOPE THROUGH THE TROCAR THE INSIDE OF THE PATIENT'S BODY APPEARED DARK. THE CSR INDICATED THAT THE OR NURSE INDICATED TO HER THAT A RESTART OF THE SYSTEM WAS PERFORMED; HOWEVER, THE ISSUE RECURRED AND THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN. THE CSR INDICATED THAT THE NEXT DAY AFTER THE CUSTOMER'S REPORT, SHE WENT OUT TO THE SITE AND TESTED THE CAMERA HEAD AND OPTIC. THE CSR INDICATED THAT BOTH THE CAMERA AND OPTIC FUNCTIONED WELL. THE CSR INDICATED THAT THE OR NURSE REPORTED THAT THE PATIENT IS DOING FINE. THE CSR ALSO INDICATED THAT SHE HAS ADVISED THE OR NURSE THEY SHOULD CONTACT ISI TECHNICAL SUPPORT ENGINEERING IMMEDIATELY FOR TROUBLESHOOTING ASSISTANCE TO PREVENT FUTURE CONVERSIONS OF DA VINCI SURGICAL PROCEDURES. ISI HAD MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE CONCERNING THE REPORTED EVENT, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SITE. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI CARDIAC-THORACIC PROCEDURE, THE SURGEON EXPERIENCED A DARK IMAGE THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77002 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P3

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES