DAVINCI XI
Report
- Report Number
- 2955842-2023-18792
- Event Type
- Malfunction
- Date Received
- September 28, 2023
- Date of Event
- September 4, 2023
- Report Date
- September 4, 2023
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110744
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 003
Narratives
AN INVESTIGATION WAS COMPLETED 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. DURING SYSTEM CALIBRATION, THE FSE ENCOUNTERED FAULTS 25520 AND 1 ON THE SYSTEM. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) AND SWAPPED REMOTE ARM CONTROLLERS (RAC) 1 AND 2 TO RESOLVE THE ISSUE. HOWEVER, THE MTM WAS NOT IN THE CORRECT POSITION. THE FSE INSTALLED ANOTHER MTM AND RAC SINCE THE CALIBRATION COULD NOT BE COMPLETED. THE FIRST MTM REPLACEMENT WOULD ALSO NOT STAY IN THE CORRECT HOME POSITION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT YET RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.
AN INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MASTER TOOL MANIPULATOR (MTM) WAS ANALYZED, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING FAILURE ANALYSIS. VISUAL INSPECTION AND TESTS WERE PERFORMED. NO ISSUES WERE FOUND. THE REPORTED FAILURE COULD NOT BE REPRODUCED BUT WAS CONFIRMED VIA FIELD EVALUATION THROUGH LOGS REVIEW. THE REMOTE ARM CONTROLLER (RAC) WAS ANALYZED AND FAILED WITH ERROR 25581 DURING POWER CYCLES.
INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND NO ERRORS WERE DETECTED. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CUSTOMER CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) FOR TROUBLESHOOTING, BUT THEY COULD NOT SOLVE THE PROBLEM. ACTIONS TAKEN INCLUDED RESTARTING THE SYSTEM SEVERAL TIMES, CHECKING CABLING, PERFORMING RECOVERY FROM RECOVERABLE FAULTS. THE SURGERY WAS CONVERTED TO LAPAROSCOPY. THE PATIENT TOLERATED THE CONVERSIONS WITH NO MAJOR COMPLICATIONS. THERE WAS NO INJURY TO THE PATIENT. ALL TROUBLESHOOTING ATTEMPTS OCCURRED BEFORE THE CONVERSION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE FIELD SERVICE ENGINEER (FSE) WAS INFORMED OF RECOVERABLE FAULTS 25520 AND 1 ON THE DA VINCI SYSTEM. THE CLINICAL SALES REPRESENTATIVE (CSR) ALSO EXPLAINED TO THE FSE THAT THE CUSTOMER USED THE EMERGENCY POWER OFF (EPO) AND RESTARTED THE SYSTEM DURING TROUBLESHOOTING. HOWEVER, THE FAULTS WERE STILL PRESENT ON THE SYSTEM. THE FSE REVIEWED THE ARTEMIS ERROR LOG, AND SOME FAULTS WERE OBSERVED POINT TO A PROBLEM WITH THE LEFT MASTER TOOL MANIPULATOR (MTM). THE SYSTEM ARMS DID NOT RESPOND TO THE COMMANDS FROM THE MTM. THE PATIENT WAS DOCKED TO THE DA VINCI SYSTEM WHEN THE FAULTS OCCURRED. THE MEDICAL STAFF WAS UNABLE TO RESOLVE THE SYSTEM ISSUES AND CHOSE TO CONVERT TO LAPAROSCOPY. THERE WAS NO PATIENT HARM. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.
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 |
|---|---|---|---|---|---|---|---|
| 2157683 | DAVINCI XI | SURGEON SIDE CONSOLE, SMART PEDALS | NAY | INTUITIVE SURGICAL, INC | 380677-24 | N/A | 00886874110744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |