DAVINCI XI
Report
- Report Number
- 2955842-2026-03685
- Event Type
- Malfunction
- Date Received
- February 8, 2026
- Date of Event
- January 13, 2026
- Report Date
- March 8, 2026
- 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
- IT
- Reporter Occupation
- 003
Narratives
ANNEX CODES C AND D HAVE BEEN CHANGED.
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS NOT ABLE TO REPRODUCE THE ISSUE BUT DID MAKE ELECTRICAL MECHANICAL ADJUSTMENTS. NO PARTS WERE REPLACED. SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN REQUESTED TO INVESTIGATE THE REPORTED EVENT. AT THIS TIME, THE FSE INVESTIGATION HAS NOT BEEN COMPLETED.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE WITH DUAL CONSOLE, THE CUSTOMER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A NON-RECOVERABLE ERROR 40067 APPEARED. THE TSE CONFIRMED ERROR 40067 IN THE LOGS POINTING TO THE SECOND SURGEON SIDE CONSOLE (SSC). THE CUSTOMER CONTINUED AND COMPLETED THE PROCEDURE WITH THE OTHER SSC. THERE WAS NO REPORTED INJURY. THE PROCEDURE WAS NOT DELAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348640 | DAVINCI XI | SURGEON SIDE CONSOLE, SMART PEDALS | NAY | INTUITIVE SURGICAL, INC | 380677-28 | N/A | 00886874110744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |