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

Model Number	400272-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the harmonic ace instrument's blade broke.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during a dissecting task, a blade on an instrument broke.The broken part completely detached from the instrument, but no fragments fell into the patient.The instrument was inspected prior to use.The surgeon reported no prior issues with the functionality of the instrument during the surgical procedure and stated that the instrument did not collide with any other hard material or instruments.The surgeon does not know what caused the instrument to break.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the harmonic ace instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause is attributed to use conditions.Damaged blades result from blade scratches 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 insert, leading to blade failure.Blade damage may be detected by the generator with a solid tone or an error.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic insert was analyzed and found to have broken blade at the base of the blade.A piece approximately 19mm long was found to be broken off, confirming that a fragment detached from the instrument.The broken piece of the blade was returned.Components adjacent to this broken blade do not show damage.The complaint was confirmed by failure analysis.The probable root cause is attributed to use conditions.Damaged blades result from blade scratches 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 insert, 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 ; 4085232100
• MDR Report Key: 23761936
• Report Number: 2955842-2025-47929
• Device Sequence Number: 18640248
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)L11241114
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: L11241114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/28/2026; 03/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/12/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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