BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3905477 · Received July 1, 2014

    Report

    Report Number
    2955842-2014-03989
    Event Type
    Other
    Date Received
    July 1, 2014
    Date of Event
    October 7, 2013
    Report Date
    February 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCO WAS RETURNED TO ISI AND EVALUATED. THE DOCO FAILED A VIDEO TEST AND THE CUSTOMER REPORTED FAILURE MODE OF LOSS OF RIGHT EYE VIDEO WAS REPLICATED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED 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 SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. DURING THE SURGICAL PROCEDURE, AN ERROR CODE 45312 OCCURRED FOUR TIMES. AN ERROR CODE 45312 IS A RECOVERABLE FAULT THAT SIGNIFIES THAT THE DISPLAY COORDINATOR (DC) DETECTED LOSS OF THE RIGHT PRIMARY CAMERA-VIDEO INPUT. IN ADDITION, AN ERROR CODE 45310 OCCURRED THREE TIMES DURING THE SURGICAL PROCEDURE. AN ERROR CODE 45310 IS A RECOVERABLE FAULT THAT SIGNIFIES THAT THE DC DETECTED LOSS OF BOTH PRIMARY CAMERA-VIDEO INPUTS. EACH TIME THE ERROR CODES OCCURRED, THE SURGICAL STAFF WAS ABLE TO OVERRIDE AND RECOVER FROM EACH FAULT. TOWARDS THE END OF THE SURGICAL PROCEDURE, AN ERROR CODE 309 AND 252 OCCURRED. BOTH ERROR CODES ARE NON-RECOVERABLE EMERGENCY STOP MESSAGES. THE ERROR CODE 252 SIGNIFIES THAT ONE OF THE MASTER SUPERVISORY CONTROLLER'S (MSC) INTERFACES TIMED OUT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PARTIAL THYMECTOMY PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A NON-RECOVERABLE ERROR CODE WITH THE DA VINCI SYSTEM.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL THYMECTOMY FOR A MEDIASTINAL MASS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT(S) AND SUPPLEMENTAL MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. ACCORDING TO THE OPERATIVE REPORT, AN UNSPECIFIED UNRECOVERABLE FAULT OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE AFTER THE DA VINCI SYSTEM WAS POWER CYCLED WITH A BREAKER RESET. THE ISSUE REPORTEDLY PERSISTED. THE SURGICAL STAFF DID NOT HAVE A BACK-UP CAMERA CABLE FOR TROUBLESHOOTING. DUE TO THE REPORTED ISSUE WITH THE DA VINCI SYSTEM, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PARTIAL THYMECTOMY PROCEDURE TO AN OPEN CHEST PROCEDURE REQUIRING A STERNOTOMY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(4) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE RESOLVED THE ISSUE OF THE RIGHT EYE VIDEO BY REPLACING THE DOUBLE CAMERA CONTROLLER (DOCO). THE FSE THEN TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. AFTER THE DA VINCI SURGERY WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT DEVELOPED LEFT ARM SWELLING. A DOPPLER STUDY SHOWED LEFT AXILLARY AND BRACHIAL VEIN THROMBOSIS. ANTICOAGULATION THERAPY WAS PROVIDED TO THE PATIENT. ON (B)(6) 2013 THE PATIENT HAD COMPLAINTS OF CONTINUED LEFT ARM PAIN. ON (B)(6) 2013, A LEFT ARM VENOGRAM AND ANGIOPLASTY OF THE LEFT SUBCLAVIAN VEIN WERE PERFORMED. A STENT WAS ALSO PLACED IN THE LEFT INNOMINATE VEIN. ON (B)(6) 2013, A TOTAL THYROIDECTOMY WAS PERFORMED FOR MULTINODULAR GOITER. ON (B)(6) 2014, A CT ANGIO OF THE CHEST SHOWED THAT THE PATIENT'S UPPER THORACIC AORTA WAS INCOMPLETELY OPACIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385021 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O| R