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

Model Number	480275-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cutting tip/blade of the harmonic ace instrument was fractured.No fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the harmonic ace instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have broken blade at the mid-section of the blade.A piece approximately 9mm long was found to be broken off, confirming that a fragment detached from the instrument.The broken piece of the blade was not returned.Components adjacent to this broken blade do not show damage.The probable root cause is attributed to use conditions.Broken blades result from blade scratches and damage caused by contact with other instruments or hard metal objects (e.G., staples, clips, etc.) while the instrument is activated.These initial damages can worsen due to the ultrasonic vibrations of the harmonic ace blade, leading to blade failure.Blade damage may be detected by the generator with a solid tone or an error.This issue can be resolved by using an alternate instrument to complete the procedure.No additional actions are required given that this issue will continue to be tracked per wi 859369 (quality data review meetings).

• 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: 50910833
• Report Number: 2955842-2026-40136
• Device Sequence Number: 17586933
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)280131(10)K11260103
• 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,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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: K11260103 0210
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2026
• 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