DAVINCI XI
Report
- Report Number
- 2955842-2026-04705
- Event Type
- Malfunction
- Date Received
- February 17, 2026
- Date of Event
- January 28, 2026
- Report Date
- March 23, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110720
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WAS ANALYZED AND THE ERROR 1162 WAS FOUND INDICATING AC MAGNETIC CANNULA SENSOR FAULT COUPLED WITH ERROR 1105 INDICATING AC SWITCH ERROR, INVALID CANNULA, CONFIRMING THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING PASSED WITHIN SPECIFICATIONS. THE USM WAS THEN INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. ONCE TESTING WAS COMPLETED. THE CANNULA MOUNT AND THE ACS WAS INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. THE REPORTED ISSUE WAS CONFIRMABLE USING LOGS; C-33 ERRORS LOGGED CONSISTENTLY BETWEEN 12/11/2025 AND 1/28/2026. M-36 ERRORS LOGGED ON 12/11/2025 AND 1/30/2026, M-10/M-12 LOGGED ON 12/11/2025, M-12 LOGGED ON 1/2, 1/30/2026 RELATED TO FOOTSWITCH ISSUES. M-18 ERRORS LOGGED ON 12/11/2025, M-02 LOGGED ON 1/9/2026 ALSO OF CONCERN. FA INSPECTION WAS ABLE TO REPLICATE AND CONFIRM CRITICAL FAILURE MODE; UNIT TESTED ON SYSTEM, PRESENTS C-33/C- ERROR ON STARTUP (3/12/2026 10:49 AM US-GA). C-00, M-0B ERRORS IN ERBE LOGS.
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 UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE USING AN XI SYSTEM, THE CUSTOMER WAS RECEIVING 1162 ERRORS ON UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 2 ON CASE SETUP. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO PERFORM A HARD POWER CYCLE OF THE SYSTEM; HOWEVER, THE 1162 ERROR REAPPEARED ON USM 2 AFTER THE RESTART. THE CUSTOMER PLANNED TO CONSULT WITH THE SURGEON ABOUT PERFORMING CASES WITH THREE ARMS OR PERFORMING THEM NON-ROBOTICALLY. LATER, SHE CALLED BACK TO REPORT THAT THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT THE STOW FUNCTION AND DEPLOY FOR DRAPING WERE NOT AVAILABLE. SHE ALSO MENTIONED THAT THE SYSTEM WAS GOING TO BE USED WITH ONLY THREE ARMS AND INQUIRED WHETHER IT WAS SAFE TO PROCEED. THE TSE INFORMED HER THAT, IF THE SURGEON WAS COMFORTABLE PROCEEDING WITH A THREE-ARM SYSTEM, THE ARMS WOULD NEED TO BE MANUALLY DEPLOYED FOR DRAPING AND MANUALLY STOWED TO CONTINUE WITH THE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 567418 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-51 | N/A | 00886874110720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | DA VINCI INSTRUMENTS AND ACCESSORIES |