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

Model Number	400272-04
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic ace insert instrument was analyzed, and the findings did not replicate or confirm the customer reported event.The instrument was placed and driven on an in-house generator and passed energy recognition test.There was no physical damage observed on the blade during testing that would have caused energy recognition failure.The instrument was fully functional.Additional findings that not reported by site: the instrument was found to have teflon pad damage.The teflon pad was torn at the distal end of the pad.A piece measuring approximately 0.09" x 0.06" was found to be broken off, confirming that a fragment detached from the instrument.The broken piece was not returned.The probable root cause of the teflon pad damage is attributed to use conditions.Damage is caused by heat generation when activating the harmonic insert with little to no tissue between the pad and the blade itself.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the harmonic ace instrument could not be used during the operation.The procedure was completed with no patient harm.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument showed ¿reduce the pressure of the blade of the instrument¿ error.It was changed another instrument.

• 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 ; 4085232100
• MDR Report Key: 25105265
• Report Number: 2955842-2026-24064
• Device Sequence Number: 9396315
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)K10250702
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112584
• 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): 05/06/2026

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: 400272-04
• Device Catalogue Number: 400272
• Device Lot Number: K10250702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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