DAVINCI SI
Report
- Report Number
- 2955842-2022-16051
- Event Type
- Malfunction
- Date Received
- December 20, 2022
- Date of Event
- November 21, 2022
- Report Date
- November 21, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K123463
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 003
Narratives
BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A RECOVERABLE ERROR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED ERROR 23/30 ON PATIENT SIDE MANIPULATOR (PSM) 1 WHEN MOVING THE Z-AXIS SET UP JOINT (SUJ) 1 POINTING TO A BROKEN/DAMAGED WIRE IN SUJ HARNESS. SUJ 1 WAS REPLACED TO FIX THIS ISSUE. THE FSE IDENTIFIED ERROR 16 WHEN INSTRUMENTS WERE INSTALLED AND ERRORS 23000, 23013, 23015, 230026 POINTING TO FAULTY ENCODERS AND COMMUNICATION ISSUES WITH THE PSM 1. THE PSM1 WAS REPLACED TO RESOLVE THIS ISSUE. THE REMOTE ARM CONTROLLER BOARDS (RAC) 3 WAS ACCIDENTLY DAMAGED BY THE FSE AND WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE SUJ AND THE RAC FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. ISI HAS RECEIVED THE PSM, HOWEVER, AT THIS TIME, EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT ENGINEER (TSE) WHEN THE CALLER CALLED FOR ASSISTANCE AND WHEN THE FSE WAS ONSITE TO DO TROUBLESHOOTING. INVESTIGATION REVEALED MULTIPLE ERRORS THAT MAY HAVE BEEN RELATED TO THE SYSTEM ISSUE. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A GENERAL SURGERY PROCEDURE WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS ON THE PATIENT SIDE MANIPULATOR. FAILURE ANALYSIS OF THE USM ARM CONFIRMED A COMPONENT FAILURE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED FAILURE (INSTRUMENT ENGAGEMENT / RECOGNITION) WAS CONFIRMED DURING VISUAL INSPECTION. THE CANNULA MOUNT WILL BE REPLACED AS A FIX. THE SETUP JOINT (SUJ) ALSO WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REMOTE ARM CONTROLLER BOARDS (RAC) AND SET UP JOINT (SUJ) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE RAC UNIT WAS ANALYZED BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. IT WAS POSSIBLE THE BOX WAS DAMAGED WHEN THE RAC WAS RETURNED. THE RAC WAS INSTALLED ONTO A TEST SYSTEM, WHERE IT RAN FOR TEN POWER CYCLES AND SAT IDLE FOR ONE HOUR. THE SYSTEM TEST WAS COMPLETED WITH NO PROBLEMS DETECTED. THE SUJ WAS ANALYZED, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA THE LOGS.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A RECOVERABLE ERROR AND ARM 1 WAS YELLOW. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SAID HE REMEMBERED IT WAS ERROR 16, BUT HE WAS NOT SURE. SYSTEM WAS NOT CONNECTED TO ONSITE. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CSR TO RESTART THE SYSTEM INCLUDING THE BREAKERS. AFTER RESTART, THE OPTION TO DISABLE THE ARM WAS GIVEN. TSE GUIDED HIM TO DISABLE THE ARM 1. CSR EXPLAINED THAT SURGEON NEEDED ALL ARMS AND THEREFORE SURGEON DECIDED TO CONVERT TO A LAPAROSCOPIC SURGERY. THE CSR SENT PICTURES OF THE LOGS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITHOUT ANY REPORTED INJURY TO THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THE DA VINCI SYSTEM COULD NOT BE USED AND THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY AND COMPLETED SUCCESSFULLY. PATIENT INFORMATION CANNOT BE DISCLOSED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447029 | DAVINCI SI | PATIENT SIDE CART, 4-ARM, RECERTIFIED | NAY | INTUITIVE SURGICAL, INC | 380675-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |