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	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the harmonic ace teflon pad was melted.The user completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic ace instrument was analyzed and found to have teflon pad damage.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 probable root cause of the teflon pad damage is attributed to use conditions.Damage is caused by heat generation when activating the harmonic ace blade with little to no tissue between the pad and the blade itself.This issue can be resolved by using an alternate instrument to complete the procedure.

• 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: 50463648
• Report Number: 2955842-2026-37031
• Device Sequence Number: 10263858
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)271031(10)K11251002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: K11251002 0238
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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