DAVINCI XI
Report
- Report Number
- 2955842-2025-43523
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- October 14, 2025
- Report Date
- March 3, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110898
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
UPDATED ANNEX C - INV FINDINGS DESC 1 TO C0201 - ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED. UPDATED ANNEX D - CONCLUSION DESC 1 TO D02 - CAUSE TRACED TO COMPONENT FAILURE.
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. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE OR CONFIRM THE CUSTOMER-REPORTED COMPLAINT. THE REPORTED ISSUE WAS CONFIRMED THROUGH SYSTEM LOGS: AN ERBE ENERGY ACTIVATION WAS HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE BLUE LOWER BIPOLAR PORT ON THE ERBE GENERATOR WHILE USING THE BIPOLAR FUNCTION AND ALSO ERROR M-02. DURING VISUAL INSPECTION, THE UNIT WAS FOUND TO HAVE MINOR SCUFFS ON THE GREY BEZEL AND SCRATCHES ON THE HEATSINK. THE ERBE WAS TESTED USING THE SYSTEM, AND IT ENERGIZED AND CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ANY ISSUES. THE LOG ERROR M-02 DATED 14-OCT-2025 WAS NOTED. THE ERBE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE OF THE CUSTOMER-REPORTED FIRING ISSUE ON THE ERBE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND THE FAILURE ANALYSIS RESULTS. IN-HOUSE TESTING OF THE RETURNED UNIT DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED EVENT. HOWEVER, SYSTEM LOGS CONFIRMED THAT THE ISSUE DID OCCUR IN THE FIELD. THIS ISSUE CAN BE ADDRESSED THROUGH TROUBLESHOOTING OR REPLACEMENT OF THE GENERATOR.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) REP. CONTACTED ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE FORCE BIPOLAR INSTRUMENT'S ENERGY FUNCTIONED ONLY FOR A SHORT PERIOD BEFORE CUTTING OUT DURING USE WITH THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. TROUBLESHOOTING BEGAN WITH THE CUSTOMER CHANGING BLUE CORDS, POWER CYCLING THE ERBE, AND SWAPPING MONOPOLAR PORTS, BUT THESE ACTIONS DID NOT RESOLVE THE PROBLEM. AFTER POWER CYCLING THE ERBE, ISSUES WITH MONOPOLAR ENERGY ALSO BEGAN TO APPEAR. THE CUSTOMER COMPLETED THE CASE ROBOTICALLY BY UNDOCKING TO USE ADVANCED ENERGY WITH THE HARMONIC, THEN REDOCKING. TSE IDENTIFIED MULTIPLE ENERGY ACTIVATION HALTED ERRORS FOR BOTH MONOPOLAR AND BIPOLAR PORTS IN THE SYSTEM LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1541739 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 381121-39 | N/A | 00886874110898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |