DA VINCI SI SURGICAL SYSTEM
Report
- Report Number
- 2955842-2014-00680
- Event Type
- Death
- Date Received
- February 6, 2014
- Date of Event
- December 13, 2011
- Report Date
- January 7, 2014
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER
Narratives
AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR SYMPTOMATIC LEIOMYOMAS WITH PELVIC PRESSURE AND POST-MENOPAUSAL BLEEDING. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT WAS ADMITTED ON (B)(6) 2011. OPERATIVE FINDINGS INCLUDED DENSE ADHESIONS AND MULTIPLE LEIOMYOMAS. THE ANESTHESIA PORTION OF SURGERY STARTED AT 1100. AT 1430 THE ROBOTIC PORTION OF THE SURGERY WAS COMPLETED AND THE PROCEDURE WAS CHANGED TO TRADITIONAL LAPAROSCOPIC SURGERY IN ORDER TO PERFORM MORCELLATION OF THE UTERUS. THE PROCEDURE PROCEEDED WITHOUT DIFFICULTY UNTIL 3/4 COMPLETED. PER THE OPERATIVE REPORT, APPROXIMATELY HALFWAY THROUGH THE MORCELLATION PROCESS, THE PATIENT ABRUPTLY HAD NO BLOOD PRESSURE OR PULSE NOTED. AT 1438, THE PATIENT'S OXYGEN SATURATION AND B/P DROPPED. THE SURGERY WAS THEN STOPPED. AT 1440, CPR WAS STARTED AND A CODE WAS CALLED AT 1441. THE PATIENT FAILED TO RESPOND TO ANY CODE INTERVENTION MEASURES. THE PATIENT'S TIME OF DEATH WAS AT 1455 ON (B)(6) 2011. THE CAUSE OF DEATH WAS UNKNOWN. THE HOSPITAL OFFERED A PRIVATE AUTOPSY AT THE HOSPITAL'S EXPENSE. ON (B)(6) 2011, AN AUTOPSY NOTED THE FOLLOWING FINAL ANATOMIC DIAGNOSES: STATUS POST LAPAROSCOPIC SURGICAL HYSTERECTOMY, HEMOPERITONEUM APPROXIMATELY 1200 CC OF BLOOD, SUBSEROSAL AND INTRAMURAL LEIOMYOMAS OF UTERUS, ANTHRACOSIS OF LUNGS AND MEDIASTINAL LYMPH NODES, MODERATE TO SEVERE AND STATUS POST OLD APPENDECTOMY. THE CAUSE OF DEATH WAS NOTED AS, SURGICAL COMPLICATIONS DURING LAPAROSCOPIC HYSTERECTOMY. ON (B)(6) 2011, A SECOND REVIEW AUTOPSY PERFORMED PER THE FAMILY'S REQUEST NOTED: IMMEDIATE CAUSE OF DEATH: ACUTE PERITONEAL HEMORRHAGE VS AIR EMBOLISM VS ENDOTRACHEAL CUFF ALTERATION. UNDERLYING CAUSE OF DEATH: COMPLICATIONS OF LAPAROSCOPIC [SIC] /ROBOTIC HYSTERECTOMY FOR LEIOMYOMATOSIS (UTERINE FIBROIDS) & DYSFUNCTIONAL UTERINE BLEEDING. THE MECHANISM OF DEATH WAS NOTED AS, CARDIAC ARREST WITH ASYSTOLE AND PULSELESS ELECTRICAL ACTIVITY. PER THE FLORIDA CERTIFICATE OF DEATH SIGNED BY A PHYSICIAN ON (B)(4) 2012, THE CAUSE OF DEATH WAS CARDIAC ARREST DURING SURGERY; ETIOLOGY UNKNOWN. PER THE AFFIDAVIT OF A PHYSICIAN DATED 01/09/2013, IT WAS NOTED, IT IS IMPOSSIBLE TO DETERMINE WITH 100% CERTAINTY WHETHER MS. [THE PATIENT'S SURNAME] PASSED AWAY BECAUSE OF A CO2 EMBOLUS OR FROM HEMORRHAGING. BOTH ARE RECOGNIZED COMPLICATIONS OF THIS PROCEDURE AND ARE NOT AN INDICATION OF A DEVIATION FROM THE STANDARD OF CARE. THE PHYSICIAN FURTHER NOTED THAT HE FELT THAT THERE WAS NO MEDICAL NEGLIGENCE ON THE PART OF SURGEON. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED CARDIAC ARREST WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, ACCORDING TO THE PATIENT'S CERTIFICATE OF DEATH, THE CAUSE OF THE CARDIAC ARREST IS UNKNOWN.
ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS CONTACTED 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)(4) 2011. ACCORDING TO THE SYSTEM LOGS, AN ERROR CODE 23009 OCCURRED APPROXIMATELY 1.5 HOURS INTO THE DA VINCI SURGICAL PROCEDURE. AN ERROR CODE 23009 SIGNIFIES THAT AN UNEXPECTED JUMP IN THE ENCODER SIGNAL OCCURRED. THIS ERROR IS MOST COMMONLY CAUSED BY A FAILED ENCODER. IN RARER CASES, IT CAN BE CAUSED BECAUSE MANIPULATORS COLLIDED. IT IS ALSO SOMETIMES POSSIBLE TO HAVE A JERK ERROR OCCUR IF SOMEONE IS PHYSICALLY MOVING THE ARMS AROUND DURING SYSTEM STARTUP. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT WAS FOUND TO HAVE NO BLOOD PRESSURE OR PULSE DURING THE MORCELLATION PROCESS. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURIES AND SUBSEQUENT DEMISE ARE UNKNOWN.
AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT INDICATES THAT EVENTUALLY, THE ROBOTIC ASSISTANCE WAS COMPLETED AND THE PATIENT WAS RETURNED TO THE TABLE, UPON WHICH TIME THE MORCELLATION PROCESS WAS BEGUN TO REMOVE THE UTERUS, OVARIES, FALLOPIAN TUBES, AND FIBROIDS. THE LEGAL COMPLAINT ALSO INDICATES THAT APPROXIMATELY HALFWAY THROUGH THE MORCELLATION PROCESS, THE PATIENT, HAD NO BLOOD PRESSURE OR PULSE. DUE TO ASYSTOLE, A CODE WAS CALLED AT 2:41 PM. THE PATIENT SUBSEQUENTLY PASSED AWAY AT 2:55 PM THAT SAME DAY. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. ON (B)(4) 2014, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS PRESENT DURING A PORTION OF THE REPORTED DA VINCI SURGICAL PROCEDURE. THE CSR STATED THAT AFTER THE EVENT OCCURRED, HE SPOKE TO THE SURGEON, THE SITE'S CHAIR OF THE ROBOTICS COMMITTEE, THE SITE'S CHAIR OF THE GYN COMMITTEE, AND THE ANESTHESIOLOGIST. THE CSR STATED THAT THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE DA VINCI HYSTERECTOMY PROCEDURE WENT SMOOTHLY AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. BEFORE THE MORCELLATION PROCESS WAS INITIATED, THE CSR INDICATED THAT THE PATIENT WAS UNDOCKED FROM THE DA VINCI SURGICAL SYSTEM AND HEMOSTASIS WAS CONFIRMED. ABOUT 15-30 MINUTES AFTER THE MORCELLATION PROCESS WAS STARTED, THE SURGICAL STAFF NOTICED BLOOD SPILLING FROM THE PATIENT'S VAGINA. THE CSR WAS INFORMED THAT THE PATIENT PASSED AWAY DUE TO HEMORRHAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77835 | DA VINCI SI SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. | IS3000 A6.0P8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Death |