MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; HARMONIC ACE

Model Number	420275-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the blade head of the harmonic ace instrument was severely broken.Use of the instrument was discontinued, and it was replaced to the backup.No fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the blade was broken off the harmonic ace instrument.The instrument did not collide with any other instrument or tool during the procedure.There are no photos and/or videos of this event available for isi review.Patient demographics were requested but were unable to be provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis (fa).The harmonic ace instrument was tested, and fa could not replicate nor confirm the reported complaint.The harmonic ace instrument does not contain any blades.No product issue was identified.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 22744529
• Report Number: 2955842-2025-33365
• Device Sequence Number: 7404722
• Product Code: NAY
• UDI-Device Identifier: 00886874111765
• UDI-Public: (01)00886874111765(10)K10220131
• 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): 07/18/2025

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: 420275-03
• Device Catalogue Number: 420275
• Device Lot Number: K10220131 678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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