MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Energy; Vessel Sealer Curved

Model Number	480522-02
Medical Device Problem Codes	Break (1069); Failure to Seal (4070)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sealing was not completed when using a vessel sealer curved instrument.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the vessel sealer curved instrument to perform failure analysis (fa).Fa was not able to confirm nor reproduce the customer reported complaint.The instrument was tested on an in-house system, and it passed the self-tests.The instrument moved intuitively with full range of motion in all directions and the grip tips opened and closed properly. the vessel sealer curved instrument passed energy delivery testing in various grip orientations and also passed the electrical continuity test and the cut test.A review of the logs found that the instrument was used for a total of 440 seconds.During that time the instrument generated two activation errors.Additional evaluation found the vessel sealer curved instrument had the lower grip tip broken at the distal end.The broken piece measured approximately 0.87mm x 1.75mm and was not returned with the instrument.

• 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 ; +1(408)523-2100
• MDR Report Key: 50927510
• Report Number: 2955842-2026-40140
• Device Sequence Number: 10759105
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: U10251011 0028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2025
• 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