MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; 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	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) product has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the blade of the harmonic ace instrument fractured and a fragment fell inside the patient.There were no instrument collisions during the case.The fractured fragment was removed during the same surgical procedure which was completed robotically.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Device evaluation: intuitive surgical, inc.(isi) received the harmonic ace instrument insert for failure analysis evaluation.The harmonic ace instrument insert was found to have a broken blade.The blade broke at roughly 0.362¿ from the base.The broken piece was not returned.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI
• 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: 23744910
• Report Number: 2955842-2025-47765
• Device Sequence Number: 12879054
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)L10250114
• 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
• Report Date (Section B): 02/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 400272-04
• Device Catalogue Number: 400272
• Device Lot Number: L10250114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown