DAVINCI XI
Report
- Report Number
- 2955842-2019-10621
- Event Type
- Death
- Date Received
- August 9, 2019
- Date of Event
- July 15, 2019
- Report Date
- July 15, 2019
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A4, A5, A6, B7, G4, G7 AND H2. BASED ON ON SITE ID QUERY, IT WAS CONFIRMED THAT ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: VESSEL SEALER INSTRUMENT, WHICH IS A SINGLE USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED (B)(6)2020.
ON (B)(6) 2019, A TELECONFERENCE WAS HELD, WITH REPRESENTATION FROM INTUITIVE SURGICAL, INC. (ISI) AND FROM CENTERPOINT MEDICAL CENTER (MISSOURI HEALTH CARE ASSOCIATION (HCA)) TO DISCUSS THE EVENT THAT OCCURRED AT THE SITE AND ENDED IN A PATIENT¿S DEATH ON (B)(6) 2019. THE LIST OF PARTICIPANTS FROM THE HOSPITAL INCLUDED THE FOLLOWING: CHIEF MEDICAL OFFICER, CHIEF NURSING OFFICER, COO OF ROBOTIC SURGERY, ROBOTICS PHYSICIAN, MULTIPLE SURGEONS, STRATEGY AND MARKET DEVELOPMENT, AND VARIOUS OTHER EXECUTIVES (VP AND DIRECTOR LEVEL). DURING THE TELECONFERENCE, THE FOLLOWING DETAILS WERE PROVIDED REGARDING THE EVENT, HOWEVER IT IS NOT KNOWN WHICH REPRESENTATIVE FROM THE SITE RELAYED THE EVENT DETAILS: TWO SURGEONS WERE INVOLVED IN THIS PROCEDURE, A GENERAL SURGEON AND A CARDIOTHORACIC SURGEON. JUST PRIOR TO THE EVENT, THE CARDIOTHORACIC SURGEON WAS PLACING SUTURES AND HAD ASKED A TECH TO REMOVE THE SURGICEL (A 3RD-PARTY HEMOSTATIC AGENT) THAT WAS IN USE. THE TECH HAD DIFFICULTY REMOVING THE SURGICEL THROUGH THE PORT, SO THE SURGEON TURNED FROM THE CONSOLE TO SEE IF HE COULD ASSIST. [NOTE: IN THE INITIAL REPORT, THE FOLLOWING DETAIL HAD BEEN PROVIDED: THE SURGEON STATED THAT HE WAS RESTING HIS EYES WHILE HE WAS WAITING FOR THE BEDSIDE ASSIST WHO WAS REPLACING THE SURGICEL.] DURING THE TIME THAT THE SURGEON WAS NOT VIEWING THE SURGICAL FIELD THROUGH THE CONSOLE, THE NEEDLE DRIVER INSTRUMENT THAT WAS INSTALLED ON ARM 3 OF THE SYSTEM WAS REPORTED TO HAVE PENETRATED AND RUPTURED THE PATIENT¿S AORTA. THE PATIENT PASSED BEFORE THE HEMORRHAGE COULD BE CONTROLLED AND THEY WERE UNABLE TO RESUSCITATE. DURING THE TELECONFERENCE, THE CHIEF NURSING OFFICER REQUESTED INFORMATION ABOUT A ¿DRIFT" ERROR CODE, 23075, AND THE HCA ROBOTICS PHYSICIAN REQUESTED A FULL REPORT ON ERRORS, CONSOLE DATA, AND SO FORTH. ISI RESPONDED STATING THEY WILL HAVE A FULL SYSTEM PREVENTIVE MAINTENANCE PERFORMED THE FOLLOWING DAY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE DID A COMPLETE SYSTEM VERIFICATION AND THERE WERE NO ISSUES FOUND. THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND THE SET UP JOINTS (SUJ) WERE TESTED, SPECIFICALLY, AND THERE WERE NO ISSUES FOUND. IN ADDITION, SYSTEM LOG INFORMATION WAS PROVIDED TO THE SITE, AS THEY HAD REQUESTED. A REVIEW OF THE SYSTEM LOGS WAS PERFORMED BY AN ISI PRINCIPAL PRODUCT PERFORMANCE ENGINEER, AND THE FOLLOWING INFORMATION WAS PROVIDED AS AN OVERVIEW REGARDING THE ERROR 23075 (DRIFT CODE). THE 23075 OCCURRENCES WERE UNRELATED AS THE TIMING OF THESE ERRORS DOES NOT CORRELATE WITH THE INCIDENT. THE 23075 DRIFT ERROR CODE IS A SYSTEM SAFETY MECHANISM THAT OCCURS WHEN THE SYSTEM SOFTWARE DETECTS CONDITIONS CONSISTENT WITH ONE OF THE MASTERS (MASTER TOOL MANIPULATORS) MOVING IN FOLLOWING WITHOUT THE SURGEON'S HANDS ON THE HANDLE. WHEN THIS OCCURS, THE SYSTEM WILL LOCK OUT THE PATIENT CART ARM THAT IS BEING CONTROLLED BY THE MASTER THAT DEMONSTRATES THE BEHAVIOR. A REVIEW OF THE LOGS INDICATES THAT EVERY TIME THE SYSTEM IDENTIFIED THESE POTENTIAL CONDITIONS, THE MASTER AND ASSOCIATED ARM WERE LOCKED OUT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE REPORTED OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. THERE WERE NO ERRORS AROUND THE TIME OF THE EVENT THAT INDICATE ANY UNINTENTIONAL BUMP OR MOTION OF AN ARM OR SETUP JOINT WHEN THE ARM WAS NOT EITHER BEING CLUTCHED OR UNDER SURGEON CONTROL. THE LOGS INDICATE THAT THE ALL ARMS LOCKED UPON EVERY HEAD-OUT EVENT. HOWEVER, AROUND THE TIME REPORTED FOR THE EVENT, THERE WAS AN INTERVAL FOR APPROXIMATELY 1 SECOND WHERE ONLY THE RIGHT MASTER AND ARM 3 WENT INTO FOLLOWING. (A CHECK WAS DONE ON THE LEFT MASTER, BUT CONDITIONS WERE NOT MET TO GO INTO FOLLOWING WITH ARM 1). THERE WAS A SHORT HEAD OUT EVENT DURING THIS TIME WHERE THE RIGHT MASTER AND ARM 3 WERE LOCKED BUT THEN WHEN HEAD WAS BACK IN (APPROXIMATELY 1/2 SECOND LATER), FOLLOWING CONDITIONS WERE MET FOR THE RIGHT MASTER AND ARM 3 AGAIN. LOGS WERE ALSO REVIEWED AFTER THE EVENT WHEN THE USER COULD NOT TAKE CONTROL OF THE INSTRUMENTS AND IDENTIFIED THAT INSTRUMENTS HAD BEEN REMOVED FROM THE ARMS THAT WERE BEING CONTROLLED BY THE MASTERS. THERE WERE NO INSTALLED AND ENGAGED INSTRUMENTS (READY FOR CONTROL) ASSOCIATED WITH EITHER MASTER AT THIS POINT SO IN THE FURTHER HEAD IN ATTEMPTS, THE SYSTEM DID NOT TRY TO GO INTO FOLLOWING. THERE WERE SEVERAL CAMERA MOVEMENTS DURING THIS TIME PERIOD, BUT INSTRUMENTS WERE NOT INSTALLED AND ENGAGED SO THEY COULD NOT BE CONTROLLED. THIS COMPLAINT IS BEING REPORTED FOR THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, IT WAS ALLEGED THAT THE MEGA NEEDLE DRIVER INSTRUMENT ON ARM 3 PIERCED THE AORTA. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY TO ADDRESS THE BLEEDING; HOWEVER, THE PATIENT EXPIRED ON THE TABLE. THE ROOT CAUSE OF THE OPERATIVE COMPLICATION THAT LED TO THE PATIENT'S DEATH IS UNKNOWN AT THIS TIME.
IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, IT WAS ALLEGED THAT THE MEGA NEEDLE DRIVER INSTRUMENT ON ARM 3 PIERCED THE AORTA. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY TO ADDRESS THE BLEEDING; HOWEVER, THE PATIENT EXPIRED ON THE TABLE. ON JULY-16- 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE CSR STATED AT THE TAIL END OF THE PROCEDURE JUST TWO SUTURES HAD TO BE PLACED ON THE HIATUS TO PREVENT SMALL BOWEL HERNIATION INTO THE CHEST CAVITY. THE SURGEON ALLEGES THAT HIS HEAD WAS NOT IN THE CONSOLE; HOWEVER, IT IS UNKNOWN AT THIS TIME IF HIS HANDS WERE ON THE MASTER TOOL MANIPULATORS (MTM). THE MASTER TOOL MANIPULATOR (MTM) REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE SURGEON STATED THAT HE WAS RESTING HIS EYES WHILE HE WAS WAITING FOR THE BEDSIDE ASSIST IN REPLACING THE SURGICEL (A 3RD-PARTY HEMOSTATIC AGENT) WITH NEW SURGICEL. IT WAS REPORTED THAT THE SURGICEL INSIDE THE PATIENT WAS DIFFICULT TO REMOVE THROUGH THE ASSIST PORT. AT THAT TIME, THE CSR NOTICED A POOL OF BLOOD ON A MONITOR WITH THE TIP OF THE MEGA NEEDLE DRIVER INSTRUMENT PIERCED INTO THE AORTA. AT THAT TIME, NO NEEDLE WAS BEING HELD BY THE INSTRUMENT. IMMEDIATELY THE SITE UNDOCKED THE ARMS, EXCEPT ARM 3 WHICH HAD THE MEGA NEEDLE DRIVER INSTRUMENT AND CONVERTED THE PROCEDURE TO THORACOTOMY. THEN THE MEGA NEEDLE DRIVER INSTRUMENT WAS REMOVED BY PRESSING THE SILVER TABS ON THE HOUSING, AND THERE WAS NO NEED FOR USAGE OF THE INSTRUMENT RELEASE KIT. IT TOOK APPROXIMATELY 10 MINUTES TO GET REPLACEMENT BLOOD AND FLUID. THE CSR REPORTED THAT HE HEARD THE ANESTHESIOLOGIST SAY "THAT GETTING THE BLOOD AND FLUIDS WEREN'T QUICK ENOUGH." AT THAT TIME, THE PATIENT WAS PRONOUNCED DEAD ON THE TABLE. THE CARDIOTHORACIC SURGEON HAD MENTIONED TO THE CSR THAT HE HAD ASKED THE ANESTHESIOLOGIST TO GIVE THE PATIENT AN A-LINE (ARTERIAL LINE), AND A CENTRAL LINE IV BEFORE THE PROCEDURE. HOWEVER, NEITHER LINE WAS GIVEN TO THE PATIENT AS PER THE STANDARD PROTOCOL. THE SURGEON ALSO STATED THAT FOR HIS THORACIC CASES, HE ALWAYS HAS BLOOD READILY AVAILABLE IN THE OR ROOM IF NEEDED. THERE WAS NO BLOOD READILY AVAILABLE IN THE OR. AS PER THE CSR, SINCE EVERYTHING HAPPENED TOO FAST, THE FOLLOWING WERE UNKNOWN: THE ESTIMATED BLOOD LOSS AND IF ANY BLOOD WAS ADMINISTERED TO THE PATIENT BEFORE HE EXPIRED. THERE WERE TWO PARTS TO THE PLANNED ROBOTIC PROCEDURE, THE ABDOMINAL AND THORACIC PORTIONS. THE GENERAL SURGEON COMPLETED THE ABDOMINAL PORTION OF THE PROCEDURE. THE CARDIOTHORACIC SURGEON PERFORMED THE THORACIC PORTION OF THE PROCEDURE. THE REPORTED INCIDENT HAPPENED JUST BEFORE THE COMPLETION OF THE THORACIC PORTION OF THE PROCEDURE. THE CSR HAD STATED THAT THE SURGEONS WERE PLEASED WITH THE SURGERY UP UNTIL WHEN THE INCIDENT OCCURRED. IT WAS REPORTED THAT THERE WERE JUST TWO SUTURES REMAINING THAT NEEDED TO BE PLACED BEFORE THE PROCEDURE COMPLETION. THE GENERAL SURGEON WHO COMPLETED THE ABDOMINAL PORTION OF THE PROCEDURE REPORTED TO THE CSR THAT WHEN THEY SAW THE INSTRUMENT PIERCE INTO THE AORTA, HE RECALLS THAT HE HAD HEARD THE CARDIOTHORACIC SURGEON SCREAM "WHO IS DOING THAT AND STOP THAT." THE GENERAL SURGEON STATED THAT HE SAT ON THE SURGEON SIDE CONSOLE RIGHT AWAY AND TRIED TAKING CONTROL OF THE MTMS WITH HIS HEAD IN; HOWEVER, HE COULD NOT MOVE ANY OF THE INSTRUMENTS AS THEY WERE ALLEGEDLY LOCKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674007 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-38 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death | DA VINCI INSTRUMENTS AND ACCESSORIES |