MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; PERMANENT CAUTERY HOOK

Model Number	478090-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the permanent cautery hook instrument 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
It was reported that during central processing, the permanent cautery hook instrument had a tear near the end of the instrument.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook instrument was analyzed and found to have the heat shrink torn at the roll gear-main tube interface.There is no material missing.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from excessive contact with abrasive or hard surfaces during use or reprocessing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 23822944
• Report Number: 2955842-2025-48700
• Device Sequence Number: 10067253
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)240912(10)K10240912
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 478090-03
• Device Catalogue Number: 478090
• Device Lot Number: K10240912 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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