BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 5011001 · Received August 18, 2015

    Report

    Report Number
    2955842-2015-01114
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K063220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FIELD SPECIALIST (TFS) CONDUCTED THE INVESTIGATION AND REPLACED THE CAMERA HEAD AND CABLE TO RESOLVE THE REPORTED ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CAMERA HEAD AND CAMERA CABLE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATION CONCLUDED THAT THE CAMERA HEAD EXHIBITED MECHANICAL SHOCK RESULTING IN A DAMAGED STAGE ASSEMBLY. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE CAMERA CABLE WAS DAMAGED NEAR THE CONNECTOR TO THE CAMERA HEAD. A RECURRENCE OF THE REPORTED AND OBSERVED FAILURE MODE OF DOUBLE VISION THROUGH THE 30 DEGREE ENDOSCOPE IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED. ON 08/31/2015, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE ISI CLINICAL SALES MANAGER (CSM). THE CSM STATED THAT THE SURGEON EXPERIENCED DOUBLE VISION AND HORIZONTAL LINES THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV) OF THE SURGEON SIDE CONSOLE (SSC). THE CSM ALSO INDICATED THAT IT WAS HIS UNDERSTANDING THAT THE PATIENT DID NOT SURVIVE THE SURGICAL PROCEDURE. ON (B)(6) 2015, ISI CONTACTED THE SURGEON WHO PERFORMED THE PROCEDURE ON (B)(6) 2015 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS A SMALL AND FRAIL (B)(6) FEMALE. TOWARDS THE BEGINNING OF THE SURGICAL PROCEDURE, THE SURGEON PERFORMED DISSECTION THROUGH A MINI-THORACOTOMY. AT THAT TIME, THE SURGICAL STAFF ENCOUNTERED THE DOUBLE VISION ISSUE WITH THE 30 DEGREE ENDOSCOPE. THE SURGICAL STAFF ATTEMPTED TO TROUBLESHOOT THE VISION ISSUE WITH THE ASSISTANCE OF THE OR MANAGER AND AN ISI TECHNICAL SUPPORT ENGINEER (TSE). ACCORDING TO THE SURGEON, THE SURGICAL STAFF REMOVED AND REINSERTED THE ENDOSCOPE APPROXIMATELY 10 TIMES BUT THE VISION ISSUE COULD NOT BE RESOLVED. WHILE WAITING FOR THE SURGICAL STAFF TO TROUBLESHOOT THE VISION ISSUE, THE SURGEON INDICATED THAT HE HAD TO MAKE THE THORACOTOMY BIGGER IN ORDER TO PERFORM FURTHER DISSECTION. DURING THIS PROCESS, THE PATIENT'S RIGHT ATRIUM TORE. THE SURGEON STATED THAT NO DA VINCI INSTRUMENTS OR ENDOSCOPES WERE USED WHEN THE INJURY TO THE PATIENT'S RIGHT ATRIUM OCCURRED. DUE TO BLEEDING FROM THE RIGHT ATRIUM INJURY, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGERY. THE ATRIAL INJURY WAS REPAIRED AND THE SURGICAL PROCEDURE WAS COMPLETED. THE SURGEON COULD NOT PROVIDE AN ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE, HOWEVER, HE MENTIONED THAT THE PATIENT REQUIRED 5 UNITS OF BLOOD TRANSFUSIONS. THE SURGEON STATED THAT THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 2 DUE TO MULTI-ORGAN FAILURE RELATED TO BLOOD LOSS. AN AUTOPSY WAS NOT PERFORMED ACCORDING TO THE SURGEON. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015. THE SYSTEM LOGS REVEALED THAT SYSTEM ERROR CODES 45310, 45311, AND 45312 WERE GENERATED WITHIN AN HOUR OF THE START OF THE SURGICAL PROCEDURE. A SYSTEM ERROR CODE 45310 SIGNIFIES THAT THE DA VINCI SYSTEM DETECTED LOSS OF THE LEFT AND RIGHT SURGEON'S VIDEO INPUTS. A SYSTEM ERROR CODE 45311 SIGNIFIES THAT THE DA VINCI SYSTEM DETECTED LOSS OF THE LEFT SURGEON'S VIDEO INPUT. A SYSTEM ERROR CODE 45312 SIGNIFIES THAT THE DA VINCI SYSTEM DETECTED LOSS OF ONE OR BOTH OF THE SURGEON'S VIDEO INPUTS. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE SURGEON INDICATED THAT WHILE HE WAS WAITING FOR THE SURGICAL STAFF TO TROUBLESHOOT A VISION ISSUE WITH THE DA VINCI SURGICAL SYSTEM, THE PATIENT SUSTAINED A TEAR TO THE RIGHT ATRIUM WHICH REQUIRED OPEN SURGERY TO REPAIR. THE SURGEON CLAIMED THAT HE WOULD HAVE BEEN ABLE TO CONTROL THE BLEEDING WITHOUT CONVERTING TO OPEN SURGERY IF THE DA VINCI SURGICAL SYSTEM WAS AVAILABLE FOR USE. THE SURGEON CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING AND TO COMPLETE THE SURGICAL PROCEDURE. THE PATIENT REPORTEDLY PASSED AWAY ON POST-OP DAY 2 DUE TO MULTI-ORGAN FAILURE RELATED TO THE BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MITRAL VALVE PROCEDURE, THE SURGEON EXPERIENCED DOUBLE VISION WITH THE 30 DEGREE ENDOSCOPE. THE INTUITIVE SURGICAL INC. (ISI)TECHNICAL SUPPORT ENGINEER (TSE) PROVIDED TROUBLESHOOTING STEPS INCLUDING ASSISTANCE IN RECALIBRATING A REPLACEMENT 30 DEGREE ENDOSCOPE; HOWEVER, THERE WAS NO CHANGE IN VISION. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546583 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| L| R