BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4238418 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05632
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    September 4, 2012
    Report Date
    October 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    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 FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT ON (B)(6) 2016. ISI WAS PROVIDED WITH ADDITIONAL PATIENT MEDICAL RECORDS. BASED ON THE PROVIDED MEDICAL RECORDS, POST-OPERATIVELY, THE PATIENT WENT TO RECOVERY UNEVENTFULLY AND WAS TAKEN TO THE FLOOR. THE SURGEON SAW THE PATIENT ON THE FLOOR AT ABOUT 18:30 AND NOTED SOME GOOD DEEP BREATHS, WHERE WE PUT HANDS ON HIS ABDOMEN TO SUPPORT HIS INCISION FOR COUGHING. HE HAD NO DISTENTION AT THE [SIC] POINT IN TIME. WE HAD HIM MOVING HIS FEET AND HE WAS FUNCTIONING, AND DOING THE THINGS HE NEEDED. EARLY THE NEXT MORNING, THE PATIENT COMPLAINED OF PAIN AND RECEIVED NARCOTICS. ABOUT HALF AN HOUR AFTER THAT, THE PATIENT WAS FOUND UNRESPONSIVE AND AN APPROXIMATE 20-30 MINUTE CODE WAS CONDUCTED. THE MEDICAL RECORDS NOTE, DURING THE TIME HE HAD AN ANOXIC [ABSENCE OF OXYGEN] BRAIN INJURY. THE PATIENT'S HEART RATE AND BLOOD PRESSURE WERE RESUSCITATED WITH MAXIMUM PRESSOR SUPPORT. HOWEVER, THERE WAS NO RESPONSIVENESS TO PUPILS OR CORNEAL REFLEX OR ANY KIND OF NEUROLOGIC RESPONSE TO NEUROLOGIC STIMULATION. THE PATIENT'S ABDOMEN WAS NOTED TO BE DISTENDED AND HE HAD A HEMOGLOBIN OF 5.6 [NORMAL REFERENCE RANGE 14-18]. FOLLOWING TRANSFER TO THE ICU, THE PATIENT RECEIVED 4 UNITS OF BLOOD VERY RAPIDLY, AND HIS HEMOGLOBIN CLIMBED TO 10.4. THE PATIENT REPORTEDLY HAD NO BLOOD PRESSURE, BASICALLY EVEN WITH HEMOGLOBIN OF 10 ON MAXIMUM PRESSOR SUPPORT INDICATING THAT WITH THE CARDIAC ARREST THERE HAD BEEN A MAJOR CARDIAC EVENT IN ADDITION TO THE ANOXIC EVENT. THIS WAS DISCUSSED WITH THE PATIENT'S WIFE AND FAMILY, AND THE DECISION WAS MADE TO INSTITUTE COMFORT MEASURES ONLY. THE PATIENT WAS EXTUBATED AND THE PRESSORS WERE BACKED OFF. THE PATIENT QUICKLY PASSED AWAY AT 9:15 ON (B)(6) 2012. PER A PROGRESS NOTE DATED 09/05/2012, THE SURGEON NOTED, WHAT I THINK HAS HAPPENED IS THAT HE HAS HAD AN ISCHEMIC EVENT OF HIS BRAIN IN HIS PAST. I TOLD THE FAMILY THAT THE LIKELY ETIOLOGY OF THIS WAS BLEEDING FROM A TROCAR SITE INSERTION. THE CASE ITSELF WENT WELL WITHOUT ANY EVIDENCE OF BLEEDING TO A POINT WHERE I DID NOT EVEN PUT A JACKSON-PRATT DRAIN BECAUSE I THOUGHT, THAT WAS NOT GOING TO SERVE ANY FUNCTION. IN ANY CASE, THAT MAY HAVE CAUSED THE INITIAL HYPERTENSION, WHICH LEAD TO THE CODE, WHICH LEAD TO THE ANOXIC EVENT FOR HIS BRAIN. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THE SURGEON NOTED THAT THE LIKELY CAUSE OF THE POST-OPERATIVE BLEEDING WAS DUE TO TROCAR SITE INSERTION. IN ADDITION, DETAILS REGARDING THE MANUFACTURER OF THE TROCAR, TYPE OF TROCAR USED, AND HOW THE TROCAR WAS INSERTED ARE UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, DURING THE DISSECTION OF THE PROSTATE, COMING UP ON THE LEFT SIDE, AT THE APEX, WENT A LITTLE DEEP, AND THERE WAS A SMALL 1 CM HOLE IN THE RECTUM... THIS WAS SUBSEQUENTLY CLOSED, ...AND WE GOT AN EXCELLENT CLOSURE OF THAT TINY LITTLE HOLE. THE SURGERY CONTINUED TO COMPLETION, AND A FOLEY CATHETER WAS PLACED. THE SURGEON NOTED, THERE WAS NO BLOOD ACCUMULATION AND I WAS CONCERNED ABOUT A JACKSON-PRATT DRAINAGE WITH THE RECTUM, THAT MIGHT WORK ITS WAY THROUGH IT, SO I DECIDED NOT TO LEAVE A JACKSON-PRATT DRAIN. THE SURGEON ALSO NOTED THAT PRIOR TO EVACUATION OF CO2 FROM THE ABDOMEN, THERE WAS A LITTLE INFLATION OF SOME AIR IN THE SCROTUM, THAT WAS DECOMPRESSED. NO FURTHER INTRAOPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 500 ML. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE PATIENT WAS HEMODYNAMICALLY STABLE AND WAS RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. PER THE DEATH CERTIFICATE, THE PLAINTIFF EXPIRED ON (B)(6) 2012 DUE TO BRAIN ANOXIA AS A RESULT OF CARDIAC ARREST AND POST-OP BLOOD LOSS. AN AUTOPSY WAS NOT PERFORMED. ACCORDING TO THE PATIENT'S DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS BRAIN ANOXIA DUE TO OR AS A CONSEQUENCE OF CARDIAC ARREST, POST-OP BLOOD LOSS, AND PROSTATE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719598 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death