BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3728687 · Received April 7, 2014

    Report

    Report Number
    2955842-2014-01990
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    January 20, 2012
    Report Date
    March 7, 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, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE.

    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-ASSISTED ROBOTIC CORONARY ARTERY BYPASS GRAFT PROCEDURE FOR CORONARY ARTERY DISEASE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUBSEQUENT MEDICAL RECORDS INCLUDING AUTOPSY REPORTS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S IMMEDIATE POST-OP RECOVERY IN THE HOSPITAL WAS EXCELLENT. AFTER THE DA VINCI SURGERY WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2012, THE PATIENT DEVELOPED FEVER AND SHORTNESS OF BREATH. AN EKG TEST WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A RIGHT BUNDLE BRANCH HEART BLOCK. ON (B)(6) 2012, A CARDIAC MRI REVEALED THAT THE PATIENT HAD MYOCARDITIS. THE PATIENT CONTINUED TO BE FEBRILE AND SUBSEQUENTLY BECAME HYPOTENSIVE AND HYPOXIC. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO THE CCU FOR ICU TREATMENT. THAT SAME DAY WHILE IN THE CATH LAB FOR PULMONARY ARTERY (PA) CATHETERIZATION AND PACING WIRE PLACEMENT, THE PATIENT BECAME HYPOXIC AND HYPOTENSIVE PRIOR TO THE START OF THE PROCEDURE. THE PATIENT WAS SUBSEQUENTLY INTUBATED AND THEN EXPERIENCED PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. CPR AND ACLS (ADVANCED CARDIOVASCULAR LIFE SUPPORT) WERE INITIATED. THE CODE CONTINUED FOR GREATER THAN 30 MINUTES WITHOUT RETURN OF A SUSTAINABLE PULSE AND RHYTHM. THE PATIENT EXPIRED ON (B)(6) 2012. AN AUTOPSY CONFIRMED THAT THE PATIENT HAD SEVERE ACTIVE MYOCARDITIS AND SIGNIFICANT CORONARY ATHEROSCLEROSIS. ACCORDING TO THE PATHOLOGY REPORT, THE MOST LIKELY CAUSE OF DEATH WAS CARDIAC FAILURE DUE TO SEVERE IDIOPATHIC MYOCARDITIS IN THE SETTING OF CORONARY ARTERY ATHEROSCLEROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209041 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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