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

Model Number	480522-02
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the curved vessel sealer instrument involved with this complaint perform failure analysis, and the reported error issue was not confirmed nor replicated.The instrument was tested on an in-house system.The instrument passed the self-tests multiple times without generating any errors.The instrument moved intuitively with full range of motion in all directions.The instrument was connected to an in-house e-200 energy generator and was recognized with no issues.Additional unrelated findings not reported by site: the instrument was found to have one of the grip cables loose at the proximal end.As a result, the instrument grips would not close completely.The instrument was further evaluated by an isi failure analysis engineer (fae).The initial findings were confirmed.The instrument had a loose grip cable at the proximal end.The hard grip force test was performed during advanced failure analysis and due to the grips not fully closing, the instrument failed the test multiple times.Additionally, the instrument was found to fail engagement multiple time after a few minutes of testing.The error logs were reviewed, and the parameter was found to be off, indicating that the grip axis likely failed to engage.This could possibly be due to the loose grip cable noted above.The probable root cause for the findings of failed hard grip force test was attributed to a component failure.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the curved vessel sealer instrument had an error message of ¿re-install instrument, if issue persists, discard instrument¿ that came up multiple times.The customer ended up opening a new instrument.There was no reported injury.
Additional Manufacturer Narrative
Correction: annex g - component desc 1 was updated to g04113 - seal.
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: 24571561
• Report Number: 2955842-2026-08592
• Device Sequence Number: 21186613
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/24/2026

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: U10250630 0186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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