DAVINCI XI
Report
- Report Number
- 2955842-2019-10844
- Event Type
- Death
- Date Received
- October 21, 2019
- Date of Event
- September 30, 2019
- Report Date
- September 30, 2019
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A5, A6, G4, G7 AND H2. ON(B)(6)2020 , INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SPECIALTY SALES MANAGER: IT WAS REPORTED THAT THE PATIENT WAS A 72 YEAR OLD MALE CAUCASIAN, AND NO AUTOPSY WAS CONDUCTED. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED (B)(6)2020.
AN ISI INTERNAL MEDICAL SAFETY OFFICER PROVIDED THE FOLLOWING AFTER REVIEWING THE CASE INFORMATION: BASED UPON THE INFORMATION IN THE DESCRIPTION OF EVENTS, THE CAUSE OF THE INJURY TO THE PULMONARY ARTERY DURING A DA VINCI ASSISTED LOBECTOMY THAT LED TO THE PATIENT¿S MULTIORGAN FAILURE AND SUBSEQUENT DEATH IS UNKNOWN. FURTHERMORE, THE DEGREE TO WHICH THE FRAYED CABLE FROM THE CADIERE FORCEPS CAUSED OR CONTRIBUTED TO THE PULMONARY ARTERY INJURY IS UNKNOWN.
THIS REPORT IS BEING SUBMITTED AS A CORRECTION TO THE PREVIOUS SUPPLEMENTAL. THE FOLLOWING FIELDS SHOULD HAVE BEEN UPDATED AS FOLLOWS IN THE PREVIOUS MDR THAT WAS SUBMITTED (FOLLOW-UP #2): H2 - SHOULD HAVE BEEN "CORRECTION" G3 - SHOULD HAVE BEEN "11/20/2022.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
BASED ON THE INFORMATION PROVIDED, IT IS INDETERMINABLE AS TO WHAT CAUSED OR CONTRIBUTED TO THE PULMONARY ARTERY INJURY SUSTAINED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE CADIERE FORCEPS INSTRUMENT USED IN THIS PROCEDURE WAS RETURNED TO ISI FOR FAILURE ANALYSIS WITH A REPORTED COMPLAINT OF "FRAYED WIRE" THAT WAS IDENTIFIED DURING CENTRAL REPROCESSING. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. ALTHOUGH THE CADIERE FORCEPS INSTRUMENT WAS RETURNED TO ISI WITH A COMPLAINT OF A "FRAYED CABLE," THE REPORTED INSTRUMENT ISSUE WAS IDENTIFIED BY THE SITE IN CENTRAL PROCESSING. BASED ON THE SURGEON'S FEEDBACK, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE AND THE BLEEDING OCCURRED IN AN AREA WHERE NO ROBOTIC INSTRUMENTS HAD CONTACT WITH TISSUE. THEREFORE, THERE IS NO INDICATION THAT THE ISSUE IDENTIFIED WITH THE CADIERE FORCEPS INSTRUMENT WAS RELATED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH.. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH PROCEDURE DATE OF (B)(6) 2019, AND NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY. AS A RESULT, THE PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY PROCEDURE TO CONTROL THE BLEEDING. THE PATIENT WAS IN THE ICU AND REPORTEDLY EXPIRED ON (B)(6) 2019. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH ARE UNCLEAR. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE PROCEDURE.
IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY WAS BLEEDING FROM THE PULMONARY ARTERY. AS A RESULT, THE SURGEON CONVERTED TO AN OPEN THORACOTOMY IN ORDER TO CONTROL THE BLEEDING. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE BLEEDING IS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN THE ICU AND NOT RECOVERING WELL. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI SPECIALTY SALES MANAGER (SSM) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SSM WAS PRESENT DURING THE SURGICAL PROCEDURE ON (B)(6) 2019, WHICH WAS NOT RECORDED ON VIDEO. TWO TIP-UP FENESTRATED GRASPER INSTRUMENTS WERE INSTALLED ON ARMS 1 AND 2. A CADIERE FORCEPS WAS INSTALLED ON ARM #4, AND THE ENDOSCOPE WAS INSTALLED ON ARM #3. WHEN THE EVENT OCCURRED, THE SURGEON WAS IN THE PROCESS OF FREEING UP THE PULMONARY ARTERY (PA) WITH A TIP-UP FENESTRATED GRASPER INSTRUMENT (INSTALLED ON ARM #2) IN ORDER TO GET READY TO TRANSECT THE PA WITH A STAPLER INSTRUMENT. WHILE THE SURGEON WAS DISSECTING TISSUE AROUND THE PA, BLEEDING FROM A DIFFERENT SECTION OF THE VESSEL WAS OBSERVED. BLOOD SQUIRTED ON THE ENDOSCOPE, AND AT THAT POINT, THE VISION OF THE SURGICAL FIELD WAS LOST. THE SURGEON APPLIED PRESSURE TO THE PA ON THE SECTION HE WAS DISSECTING TO CONTROL THE BLEEDING; HOWEVER, THE BLEEDING WAS NOT CONTROLLED. AT THAT TIME, THE SURGEON DECIDED TO CONVERT TO AN OPEN THORACOTOMY AND WAS THEN ABLE TO CONTROL THE BLEEDING. THE SURGICAL STAFF REMOVED, CLEANED, AND REINSERTED THE ENDOSCOPE. BY THE TIME THE ENDOSCOPE WAS REINSERTED, THE CHEST CAVITY WAS FULL OF BLOOD. AT THAT TIME, THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING VIA OPEN SURGERY. THE ESTIMATED BLOOD LOSS WAS REPORTED TO BE 2 LITERS, AND THE PATIENT HAD 6 LITERS OF BLOOD TRANSFUSION ADMINISTERED. POST-OPERATIVELY, THE PATIENT WAS IN THE ICU AND WAS IN A STABLE CONDITION FOR A FEW DAYS. HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2019 SECONDARY TO MULTI-ORGAN FAILURE. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE SSM SPOKE TO THE SURGEON THE FOLLOWING DAY REGARDING THE INCIDENT. THE SURGEON DID NOT KNOW THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION. ACCORDING TO THE SSM, THE SURGEON EXPLAINED THAT HE WAS NOT WORKING AROUND THE LOCATION OF WHERE THE BLEEDING WAS IDENTIFIED. FURTHERMORE, THE SURGEON INDICATED THAT NO ROBOTIC INSTRUMENTS WERE TOUCHING THE AREA WHERE THE BLEEDING WAS IDENTIFIED. PER THE SSM, NO TENSION WAS OBSERVED ON THE PA. THE SSM DID NOT HAVE ANY INFORMATION REGARDING AUTOPSY. THERE IS NO ALLEGATION OF ANY ISI DEVICE OR SYSTEM MALFUNCTION; HOWEVER, THE SURGEON HAD STATED THAT HE DOES NOT KNOW THE ROOT CAUSE OF HOW THE PA WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009409 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-40 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Death | DA VINCI INSTRUMENTS AND ACCESSORIES. |