DAVINCI XI
Report
- Report Number
- 2955842-2025-28770
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 13, 2025
- Report Date
- June 13, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE SFL, ACT, AND THE LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) HARNESS IN THE DISTAL SUJ.
UPON VISUAL INSPECTION, NO ISSUE WAS FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE AXES CONTROLLER SPAR BOARD (ACS) PRINTED CIRCUIT ASSEMBLY (PCA) WERE INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDE THAT THE ACS PCA ARE CONSISTENT WITH THE REPORTED EVENT AND IS THE POTENTIAL ROOT CAUSE FOR THIS ISSUE. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE.
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE AND REPLACED THE DISTAL SET-UP JOINT (DSUJ). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE DSUJ FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND THE REPORTED 26002 AND 319 ERRORS WERE CONFIRMED AND REPLICATED. IN LOG REVIEW, THE 319 ERROR WAS FOUND INDICATING NODE 194 THROUGH 198 WE DO NOT PRESENT AT STARTUP, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UP VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE ERROR 319 WAS TRIGGERED IN NORMAL MODE, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED NODE CHECK B AND C. A GOLDEN ACT WAS INSTALLED AND THE UNIT FAILED NODE CHECK B AND C, A GOLDEN SFL WAS ALSO INSTALLED, AND THE UNIT PASSED ALL TESTS. THE GOLDEN ACT WAS REMOVED AND THE ORIGINAL ACT REINSTALLED, THE UNIT WAS RETESTED AND PASSED ALL TESTS. THE ORIGINAL SFL WAS INSTALLED (WITH THE ORIGINAL ACT), UNIT WAS RETESTED AND PASSED ALL TESTS.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE 26002 ERROR, WHICH WAS ATTRIBUTED TO ARMNET 4. THE SITE WAS IN THE MIDDLE OF REBOOTING WHEN THEY CALLED IN, AND THE SYSTEM DID NOT COMPLETE THE SELF-TEST DUE TO THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM3) SET UP JOINT (SUJ) ERRORS. THE TECHNICAL SERVICE ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO PERFORM ANOTHER REBOOT, AFTER WHICH "DA VINCI IS READY" WAS HEARD, ALLOWING THE PROCEDURE TO CONTINUE AND THE CUSTOMER ENDED THE CALL. THE STAFF CALLED BACK AT THE END OF THE PROCEDURE TO REPORT ANOTHER NON-RECOVERABLE FAULT 26002 OCCURRED, LEADING TO THE DISABLING OF USM4. THE CUSTOMER ADVISED THAT THE SURGEON WAS STILL USING THE VISION SIDE CART AND ENDOSCOPE BUT HAD FINISHED USING THE USMS. THE TSE WAS UNABLE TO CONFIRM ERROR 26002 IN THE SYSTEM LOGS BUT NOTED 319 ERRORS ON ARMNET 4. THE TSE REMAINED ON THE PHONE WITH THE CUSTOMER UNTIL THEY PERFORMED A HARD REBOOT/EPO ON THE PATIENT SIDE CART, WHICH RESULTED IN A SUCCESSFUL SYSTEM REBOOT WITH NO ERRORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1603 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-22 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |