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

Model Number	480275-10
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the teflon pad of harmonic ace instrument melted.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter however the customer was unable to provide additional information.
Additional Manufacturer Narrative
The harmonic ace instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis investigation replicated and confirmed the customer reported complaint.The clamp arm was found to have melting of the teflon pad at the entire length.The component is damaged and there may be missing pieces, but the size of the missing pieces cannot be confirmed.Components adjacent to this teflon pad do not show damage.The complaint was confirmed by failure analysis.

• 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: 50216619
• Report Number: 2955842-2026-35390
• Device Sequence Number: 14976955
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)270930(10)K10250905
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 480275-10
• Device Catalogue Number: 480275
• Device Lot Number: K10250905 0077
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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