BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3619662 · Received February 10, 2014

    Report

    Report Number
    2955842-2014-00713
    Event Type
    Death
    Date Received
    February 10, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 INTRA-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO 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 EXPERIENCED INTRA-OPERATIVE BLOOD LOSS DURING A DA VINCI PROSTATECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY ON POST-OPERATIVE DAY 1. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND AUTOPSY REPORT. BASED ON THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT REPORTEDLY HAD EXCESSIVE BLEEDING DURING THE DA VINCI PROSTATECTOMY PROCEDURE. THE SURGEON SUMMARIZED THESE ISSUES IN HIS DISCHARGE (DEATH) SUMMARY BY SAYING THAT THE BLOOD LOSS WAS DUE TO DESMOPLASTIC TISSUE PLANES, NEO-VASCULARIZATION, AND A NARROW PELVIS. DESMOPLASTIC TISSUE PLANES MEANS THAT THE NORMAL PLANES BETWEEN TISSUES WERE SCARRED OR VERY DIFFICULT TO SEPARATE. THIS IS PROBABLY THE RESULT OF THE INFLAMMATORY HEALING PROCESS FOLLOWING THE PATIENT'S 2011 TURP OPERATION AND POSSIBLE EPISODES OF PROSTATIC INFLAMMATION ASSOCIATED WITH UNDERLYING BENIGN PROSTATIC HYPERTROPHY. NEOVASCULARIZATION IS A PROCESS THAT OFTEN ACCOMPANIES CANCER WHEREBY MANY SMALL CHANNEL ARTERIES AND VEINS DEVELOP AROUND THE CANCER TO HELP FEED THE TUMOR. A NARROW PELVIS LIMITS ROBOTIC ARM MOVEMENT AND MAY MAKE IT MORE DIFFICULT TO EFFICIENTLY ACCOMPLISH TASKS IN A CONFINED SPACE, SUCH AS ADDRESSING BLOOD LOSS, SUTURING, OR PLACING HEMOCLIPS. DUE TO EXCESSIVE BLEEDING, THE PATIENT DEVELOPED HYPOTENSION AND THE MOST SIGNIFICANT RESULT WAS A MYOCARDIAL INFARCTION. THE PATIENT HAD A SILENT HEART ATTACK DURING THE OPERATION, PROBABLY DURING THE TIME THAT HIS BLOOD PRESSURE WAS AT ITS LOWEST POINT. BASED ON THE PATIENT'S MEDICAL RECORDS, THE MYOCARDIAL INFARCTION WAS REFERRED TO A NSTEMI (NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION). THIS IS EVIDENCED BY BLOOD TESTS SHOWING SERIOUS ELEVATIONS IN THE CPK-MB FRACTION AND ELEVATIONS IN LEVELS OF TROPONIN. THEREFORE PORTIONS OF HIS HEART MUSCLE WERE SIGNIFICANTLY DEPRIVED OF OXYGEN AND DAMAGED WHICH AFFECTED THE HEART'S ABILITY TO FUNCTION. THE AUTOPSY SHOWED ONLY MODERATE CORONARY ATHEROSCLEROSIS. ALSO AS A RESULT OF EXCESSIVE BLEEDING AND BLOOD TRANSFUSIONS, THERE WERE SIGNIFICANT EFFECTS ON THE PATIENT'S ELECTROLYTES. THESE INCLUDED ELEVATED POTASSIUM LEVELS WHICH AFFECT THE HEART'S ABILITY TO BEAT PROPERLY AND LOW CALCIUM LEVELS WHICH AFFECT THE HEART'S ABILITY TO PUMP BLOOD EFFECTIVELY. ULTIMATELY ONCE THE PATIENT'S OPERATION WAS COMPLETED AND HE WAS IN ICU, THE DOCTORS WERE UNABLE TO GET HIS HEART TO WORK PROPERLY AS EVIDENCED BY CONTINUED LOW BLOOD PRESSURE, AND THEY COULD NOT RESUSCITATE HIM EFFECTIVELY ONCE HIS HEART STOPPED IN THE FACE OF DAMAGED HEART MUSCLE AND ABNORMAL LEVELS OF ELECTROLYTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE PATIENT LOST 3500 CC'S OF BLOOD. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE DA VINCI SURGICAL PROCEDURE TOOK 10 HOURS. THE PATIENT WAS TAKEN TO THE ICU AND THEN PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2013. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER. THE RISK MANAGER INDICATED THAT THE SURGEON INVOLVED WITH THIS COMPLAINT WAS NO LONGER EMPLOYED BY THE SITE. ACCORDING TO THE RISK MANAGER, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT AN AUTOPSY HAS BEEN PERFORMED AND THE CAUSE OF THE PATIENT'S DEATH WAS CARDIAC ARREST AND BLEEDING. THE RISK MANAGER INDICATED THAT THE SITE IS CURRENTLY REVIEWING THE CASE AND THE CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88255 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death