MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CANNULA, STANDARD, REUSABLE

Model Number	470002-08
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the instrument 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 the cannula seal was defective.It was unknown if fragments fell inside the patient.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the cannula seal for failure analysis investigation.The unit was analyzed and have bending at the distal tip of the accessory, the end which instruments exit the cannula from.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from an accidental drop of the accessory or inadvertent collisions with other objects or hard surfaces.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: CANNULA, STANDARD, REUSABLE
• 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: 23722026
• Report Number: 2955842-2025-47519
• Device Sequence Number: 21041619
• Product Code: NAY
• UDI-Device Identifier: 00886874112137
• UDI-Public: (01)00886874112137(10)NW336171
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131861
• 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): 04/22/2026

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: 470002-08
• Device Catalogue Number: 470002
• Device Lot Number: NW336171 6171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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