DAVINCI 5
Report
- Report Number
- 2955842-2025-39892
- Event Type
- Malfunction
- Date Received
- September 30, 2025
- Date of Event
- September 15, 2025
- Report Date
- October 28, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K232610
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE VIDEO IMAGE PROCESSOR (VIP) BOARD WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. UPON REVIEW OF THE ERROR LOGS, A 307 ERROR WAS FOUND POINTING TOWARDS THE VIP.
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE TOWER COMMON COMPUTE CONTROLLER (CCC) AND THE VIDEO IMAGE PROCESSOR (VIP) BOARD AS SUSPECTED COMPONENTS FOR 307 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. UPON VISUAL INSPECTION OF THE COMMON COMPUTE CONTROLLER (CCC), NO ISSUES WERE FOUND TO BE RELATED TO THE REPORTED COMPLAINT. WHILE THE REPORTED COMPLAINT WAS NOT ABLE TO BE REPLICATED DURING IN HOUSE TESTING, AN ADDITIONAL ERROR WAS TRIGGERED WHEN THE CCC WAS INSTALLED ON THE GOLDEN TESTING SYSTEM POINTING TO THE FIREFLY FIBER OPTIC CABLE (FF5) THE FIREFLY OPTIC CABLE WAS REPLACED WITH A KNOWN GOOD CABLE. THE CCC FUNCTIONED AS EXPECTED, BUT WHEN THE CABLE WAS SWITCHED BACK TO THE ORIGINAL FIREFLY OPTIC CABLE, THE SYSTEM FAILED THE TEST AGAIN. THE EVENT WAS CONFIRMED BASED ON ERROR LOG REVIEW, HOWEVER THE ISSUE WAS NOT ABLE TO BE REPLICATED DURING IN-HOUSE TESTING. WHILE A DEFINITIVE ROOT-CAUSE CANNOT BE ESTABLISHED SINCE THE REPORTED COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING, A POTENTIAL ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO A FAULT OF AN ELECTRONIC COMPONENT OR MODULE WITHIN THE AFFECTED SYSTEM COMPONENTS CAUSING A COMMUNICATION ISSUE.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, REPEATED FAULTS OCCURRED PROMPTING A RESTART, SPECIFICALLY ERROR 307. SYSTEM EVENT LOGS INDICATED ERRORS RELATING TO AN AURORA LINK ISSUE BETWEEN THE TOWER COMMON COMPUTE CONTROLLER (CCC) AND THE VIDEO IMAGE PROCESSOR (VIP) BOARD, FOLLOWED BY ERROR 307 REFERENCING THE VDCX IN THE VIP BOARD. THE CUSTOMER ATTEMPTED TO RESTART THE SYSTEM WITH NO CHANGE. AS THE PROCEDURE WAS NEARING COMPLETION, THE SURGEON CHOSE TO FINISH LAPAROSCOPICALLY. CLINICAL SALES REPRESENTATIVE (CSR) REMAINED ON THE PHONE AND PERFORMED A HARD REBOOT ON THE TOWER, AFTER WHICH THE SYSTEM POWERED ON SUCCESSFULLY WITH NO ERRORS. THE CUSTOMER DECIDED TO DISCONTINUE USE OF THE SYSTEM UNTIL THE ISSUE HAS BEEN RESOLVED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1944344 | DAVINCI 5 | VISION SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380746-40 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |