MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci; HARMONIC ACE

Model Number	480275-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection procedure, the blade tip of the harmonic ace instrument fractured and a fragment fell inside the patient.All fragments were retrieved during the same procedure which was completed robotically.
Additional Manufacturer Narrative
The harmonic ace instrument has not been received for failure analysis evaluation.

• 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 ; +1(408)523-2100
• MDR Report Key: 50356478
• Report Number: 2955842-2026-36370
• Device Sequence Number: 10111569
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)271031(10)K11251023
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480275-10
• Device Catalogue Number: 480275
• Device Lot Number: K11251023 0300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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