MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC None; HARMONIC ACE

Model Number	480275-10
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, when using the harmonic ace instrument, it was found that it was not recognized and replaced with a new one.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic ace instrument was analyzed and the complaint was not confirmed by failure analysis.The reported event with the instrument could not be replicated nor confirmed.The harmonic ace was tested on an in-house system.The instrument passed the recognition, engagement and initialization tests.The instrument moved intuitively with full range of motion in all directions.The instrument clamp arm opened and closed properly several times.Due to the missing teflon pad the energy delivery test could not be performed.Additional observation not reported by site was that the clamp arm was found to have a missing teflon pad.The complete teflon pad was not returned.Components adjacent to this teflon pad do not show damage.The probable root cause of the teflon pad damage is attributed to use conditions.Damage is caused by heat generation when activating the harmonic ace blade with little to no tissue between the pad and the blade itself.

• Brand Name: None
• Common Device Name: HARMONIC ACE
• 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: 50864047
• Report Number: 2955842-2026-39712
• Device Sequence Number: 21505525
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)271031(10)K10251030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143132
• 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): 09/22/2026

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: 480275-10
• Device Catalogue Number: 480275
• Device Lot Number: K10251030 0034
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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