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

Model Number	400272-04
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm harmonic ace instrument cannot be recognized.The procedure was completed with no reported injury.
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 a curved blade cracked at its mid - section.There also were indentations/burrs near this crack.No piece was found missing before the inhouse testing.Additional observations not reported by site were found, the harmonic insert was found to have an energy recognition failure during the in-house testing.The generator displayed an error message indicating "tighten assembly", even though the assembly was already tightened.As result of the crack, the blade broke during the in-house testing.A piece measuring proximately 11.0mm x 2.2mm broke during the test.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 ; +1(408)523-2100
• MDR Report Key: 50125306
• Report Number: 2955842-2026-34445
• Device Sequence Number: 10527591
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)K10250710
• 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
• Report Date (Section B): 08/03/2026

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: K10250710 NA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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