MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HASSON CONE

Model Number	470398-04
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the hasson cone had thermal damage on the pulley cover.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the hasson cone for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The hasson cone accessory was analyzed, and the complaint was not confirmed by failure analysis.A visual inspection did not reveal any signs of thermal damage.No product issue related to the complaint was identified.The hasson cone was found with the white clamp collar broken.No pieces were missing.The collar was found broken but still secured at the top of the cone.The probable root cause is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as accidental drops of the accessory or inadvertent collisions with hard surfaces during handling or usage.Improper cleaning during reprocessing, such as prolonged exposure of the accessory to harsh cleaning agents, can lead to cracking.

• Brand Name: NONE
• Common Device Name: HASSON CONE
• 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: 24780122
• Report Number: 2955842-2026-20298
• Device Sequence Number: 20366737
• Product Code: GCJ
• UDI-Device Identifier: 00886874112656
• UDI-Public: (01)00886874112656(10)SR244802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153126
• 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,Followup
• Report Date (Section B): 05/11/2026

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: 470398-04
• Device Catalogue Number: 470398
• Device Lot Number: SR244802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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