BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3637922 · Received February 20, 2014

    Report

    Report Number
    2955842-2014-01020
    Event Type
    Death
    Date Received
    February 20, 2014
    Date of Event
    September 28, 2010
    Report Date
    December 26, 2013
    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

    INTUITIVE SURGICAL, INC. (ISI) IDENTIFIED THAT A DUPLICATE MDR WAS SUBMITTED ON (B)(6) 2013 FOR THIS REPORTED EVENT VIA PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-02996. WHEN THE INITIAL MDR FOR THIS COMPLAINT (PATIENT IDENTIFIER = (B)(6)) WAS SUBMITTED ON (B)(6) 2014, IT WAS UNKNOWN THAT BOTH MDR'S INVOLVED THE SAME PATIENT AND REPORTED EVENT. MDR REPORT 2955842-2013-02996 HAS SINCE BEEN RETRACTED AS A DUPLICATE MDR TO THIS COMPLAINT. (B)(6). ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT IN THE IMMEDIATE DAYS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF SEVERE ABDOMINAL PAIN AND EXTREME DISTENSION OF ABDOMEN, TROUBLE STANDING OR WALKING, DIFFICULTY BREATHING, LACK OF BOWEL MOVEMENTS AND FLATUS, AND BLACK FOUL SMELLING EMESIS. THE LEGAL COMPLAINT ALSO INDICATED THAT ON (B)(6) 2010, THE PATIENT WAS TRANSPORTED TO A HOSPITAL VIA AMBULANCE AND ADMITTED FOR SEVERE ABDOMINAL SEPSIS AND INFLAMMATION OF THE ABDOMEN AND ABDOMINAL TISSUE. IN ADDITION, THE PATIENT WAS OPERATED ON IMMEDIATELY AFTER ADMITTANCE TO THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, DURING THE OPERATION DOCTORS OBSERVED THE PATIENT WAS SEPTIC AND HAD A PUNCTURED COLON. THE PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT (ICU) IN SEVERE CRITICAL CONDITION MAINTAINED BY A VENTILATOR, SO THAT THE DOCTORS COULD CONTINUE TO TREAT HER. ALSO, THE LEGAL COMPLAINT INDICATED THAT DESPITE INVASIVE MEDICAL PROCEDURES EVERY TWO DAYS OVER THE DURATION OF TWO WEEKS IN ATTEMPT TO TREAT THE PATIENT, THE SEPSIS WAS TOO ADVANCED AND IRREVERSIBLE. THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010, DUE TO SEPSIS AND HYPOTENSION CAUSED BY A PUNCTURED COLON FROM THE DA VINCI SURGICAL SYSTEM SURGERY. (B)(6). INTUITIVE SURGICAL INC. (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 SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. NO SYSTEM FAULTS/ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT CLAIMS THAT THE PATIENT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS AND A PUNCTURED BOWEL. AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AND INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IT IS ALSO UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY AND SUBSEQUENT DEMISE.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT PASSED AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

    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 HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR PELVIC MASS WITH ELEVATED CA-125 ON (B)(6) 2010 AND AT AN UNSPECIFIED DATE SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, PRE-SURGERY CLINIC NOTE, HOSPITAL ADMISSION NOTE, DISCHARGE SUMMARY AND PATHOLOGY REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING THE DA VINCI SURGERY. THE OPERATIVE REPORT WAS BRIEF AND DID NOT INCLUDE ANYTHING AFTER THE TITLE OPERATION. ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC. THE OPERATIVE REPORT STATES THAT THERE WAS EXTENSIVE INTRAABDOMINAL ADHESIONS IN THE SITE OF THE PATIENT'S PREVIOUS SURGERY. FURTHERMORE IT STATES, EXTENSIVE ADHESIONS WERE LYSED AWAY FROM THE OPERATIVE FIELD IN ORDER TO SAFELY PLACE INSTRUMENTS. AFTER COMPLETION OF THE LYSIS OF ADHESIONS, THE RIGHT LATERAL ROBOTIC PORT WAS PLACED. IT CONTINUES, THE LYSIS OF ADHESIONS TOOK APPROXIMATELY 45 MINUTES AND WAS A SIGNIFICANT PORTION OF THE OPERATIVE TIME. THE DISCHARGE SUMMARY STATES THAT THE PATIENT HAD POSTOPERATIVE MILD CONGESTIVE HEART FAILURE AND POSTOPERATIVE ILEUS. THE DISCHARGE SUMMARY WAS VERY BRIEF AND NOT DATED. THE MEDICAL RECORDS INDICATE THAT THERE WERE MULTIPLE RADIOLOGY REPORTS. THE CHEST X-RAY (CXR) REPORTS MENTION THAT THE PATIENT WAS VENTILATED. ONE OF THE CT ABDOMEN & PELVIS REPORTS STATE THAT THE PATIENT HAD A BOWEL PERFORATION. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE LEGAL DOCUMENT PROVIDED TO ISI INDICATES THAT THE PATIENT HAD A BOWEL PERFORATION, WAS VENTILATOR DEPENDENT, HAD SEPSIS AND DIED. ISI WAS NOT PROVIDED WITH ANY RECORDS PERTAINING TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107912 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| R