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	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the harmonic ace insert accessory's blade was broken.The user completed the procedure using a backup harmonic ace instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
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 broken blade.The blade broke at roughly 2.75mm from the base.The broken piece was not returned.The size of the missing piece is approximately 2.21mm x 12.05mm.Components adjacent to the broken blade did not show damage.Additionally, the instrument was connected to an in-house energy generator.The instrument failed the energy recognition test, and the instrument generated the message "replace instrument".The root cause is related to the broken blade at the distal end.The complaint was confirmed by failure analysis.The probable root cause is attributed to use conditions.Damaged blade is triggered by any inadvertent contact with staples, clips, or other instruments while the device is activated.In addition, scratches on the blade tip may also lead to premature 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: 23448026
• Report Number: 2955842-2025-43681
• Device Sequence Number: 15682631
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)L10240307
• 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): 10/31/2025

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: L10240307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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