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

Model Number	470398-04
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the hasson cone accessory involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted urology prostatectomy surgical procedure, the hasson cone accessory had a damaged crack in the clamp part.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The hasson cone was analyzed and found to be broken at the clamp of the cone.There were no missing pieces found.The complaint was confirmed by failure analysis.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 and subsequent breakage.Isi followed up with the initial reporter and obtained the following additional information: no fragment fell inside the patient.
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: 22287818
• Report Number: 2955842-2025-25945
• Device Sequence Number: 12980759
• Product Code: GCJ
• UDI-Device Identifier: 00886874112656
• UDI-Public: (01)00886874112656(10)SR215201
• 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): 06/09/2025

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: 470398-04
• Device Catalogue Number: 470398
• Device Lot Number: SR215201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• 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: Reuse
• 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