BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4238371 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05631
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    December 16, 2013
    Report Date
    October 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT AND OTHER PROVIDED MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED INTRA-SURGICAL COMPLICATIONS (INJURY TO INTERNAL MAMMARY ARTERY) AND SUBSEQUENTLY DIED WHILE UNDERGOING A DA VINCI SURGICAL RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE. AT THIS TIME, THE CAUSE OF THE VESSEL INJURY AND CAUSE OF DEATH ARE UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO DIED AFTER UNDERGOING A DA VINCI RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE FOR A LUNG MASS ON (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENTS, IT WAS ALLEGED THAT DUE TO A DEFECTIVE DESIGN OF THE DA VINCI SURGICAL SYSTEM, THE PATIENT SUSTAINED AN ARTERY INJURY TO THE RIGHT INTERNAL JUGULAR VEIN. AS A RESULT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND DETERIORATED TO ASYSTOLE, AND SUBSEQUENTLY PASSED AWAY AT THE END OF THE PROCEDURE. ISI RECEIVED THE PATIENT'S DA VINCI OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS PREVIOUSLY TREATED WITH CHEMOTHERAPY AND RADIATION IN THE LEFT LOWER LOBE FOR STAGE III LUNG CANCER AND WAS PRESENTED WITH A NEW ENLARGING LESION IN THE UPPER MEDIASTINUM/RIGHT UPPER LOBE. AFTER THE DA VINCI SYSTEM WAS DOCKED TO THE PATIENT, THE PATIENT'S CHEST WAS EXPLORED AND NO METASTATIC TISSUE WAS FOUND. A MASS WAS IDENTIFIED IN THE RIGHT UPPER LOBE FIRMLY ADHERENT TO THE MEDIASTINUM, AT THE APEX OF THE CHEST, AT THE SUPERIOR MEDIASTINUM. THE PLEURA OVER THIS AREA WAS INCISED WITH BIPOLAR CAUTERY. DURING THE COURSE OF DISSECTION OF THE INTERNAL MAMMARY ARTERY, WHICH WAS INVOLVED WITH THE MASS, AN INJURY WAS MADE TO THE RIGHT INTERNAL JUGULAR VEIN AND WAS CONTROLLED WITH CLIPS. THE WEDGE RESECTION OF THE RIGHT UPPER LOBE LESION WAS PERFORMED. A FROZEN SECTION OF THE SPECIMEN REVEALED SQUAMOUS CELL CARCINOMA, WHICH WAS INVADING THE LUNG TISSUE AND THE MEDIASTINAL TISSUE. DURING THE COURSE OF CLOSURE, THE PATIENT HAD A VENTRICULAR FIBRILLATION ARREST. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND WAS PRONOUNCED DEAD AT 12:39. ESTIMATED BLOOD LOSS FOR THE PATIENT WAS NOTED TO BE 1000 CC. THERE WAS NO REPORT OF ALLEGATION OF ANY MALFUNCTION WITH THE DA VINCI SYSTEM IN ANY OF THE PROVIDED MEDICAL RECORDS. ON (B)(6) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGEMENT DEPARTMENT INDICATED THAT THE PATIENT'S VESSEL INJURY AND SUBSEQUENT DEMISE WERE UNRELATED TO ANY EQUIPMENT ISSUES WITH THE DA VINCI SURGICAL SYSTEM. THE RISK MANAGEMENT DEPARTMENT WAS UNABLE TO DISCLOSE THE PATIENT'S AUTOPSY RESULTS. NO FURTHER INFORMATION WAS PROVIDED BY THE RISK MANAGEMENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718307 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| L| R