MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; VESSEL SEALER CURVED

Model Number	480522-02
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical surgical procedure, the vessel sealer curved instrument stopped working.The procedure was completed with no patient harm.Intuitive surgical, inc.(isi) followed up with the site to obtain additional information, however, no further details could be provided regarding the reported event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer curved instrument was analyzed and for clarification, the instrument exhibited unintuitive motion.The motion exhibited by the instrument was precise, and proportional to what was commanded by the master tool manipulator¿s (mtm¿s), however the grip tips moved in the opposite direction.This behavior was observed in the pitch and yaw directions.The instrument was found to have a dislodged main tube which caused unintuitive motion.Additional related findings not reported by site: the instrument was found to have a dislodged main tube.The two tabs and the distal end were dislodged.As a result, the instrument exhibited unintuitive motion.The complaint was confirmed by failure analysis.The probable root cause is attributed to the user.
Additional Manufacturer Narrative
The vessel sealer curved instrument was further evaluated by failure analysis engineer (fae).Initial findings confirmed.The instrument main tube tabs were dislodged and bent outwards which caused the instrument to exhibit unintuitive motion.The instrument was disassembled to check for roll gear keys damage, but no damage was found on the roll gear keys that could have potentially caused the dislodged main tube.A review of the instrument logs showed that the instrument was used for about 50 minutes for a total of 75 seal and 1 coag event, indicating that the instrument functioned well until the user complained about the failure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI ENERGY
• Common Device Name: VESSEL SEALER CURVED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24928075
• Report Number: 2955842-2026-22097
• Device Sequence Number: 21495899
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K250674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U10250814 0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown