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

Model Number	480275-12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a davinci assisted surgical procedure, the customer identified that the harmonic ace instrument had a broken tip.The procedure was completed.
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 curved blade broken at its base.A piece approximately 11.0mm x 2.1mm was found to be broken off and was returned with the instrument.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.

• 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: 50231336
• Report Number: 2955842-2026-35588
• Device Sequence Number: 10373729
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)281130(10)K10251113
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 480275-12
• Device Catalogue Number: 480275
• Device Lot Number: K10251113 0119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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