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

Model Number	470398-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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 da vinci-assisted surgical procedure, the hasson cone was found to have crack in clamp part.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did follow up and obtain additional information.No fragment fell inside the patient.No broken part was detached completely from the hasson cone.Patient information was not provided.Review of the provided image is consistent with reported complaint of cracked hasson cone.Root cause of the failure mode cannot be confirmed without the returned device.No further escalations required for the image review.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary failure of 'hasson cone broken' to be related to the customer reported complaint.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 collar allows the cannula to rotate independent of the hasson cone for robotic use.Probable root cause of the failure mode broken hasson cone are typically attributed to damage during use, which may include an accidental drop of the product or collisions with other objects or hard surfaces.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24206826
• Report Number: 2955842-2026-02514
• Device Sequence Number: 12139847
• Product Code: GCJ
• UDI-Device Identifier: 00886874112656
• UDI-Public: (01)00886874112656(10)SR250702
• 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,Followup
• Report Date (Section B): 03/13/2026

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: SR250702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 02/18/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/09/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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