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	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the permanent cautery hook instrument cover was peeling off.The procedure was completed as planned.Intuitive followed up and obtained additional information.The peeled coverings of the permanent cautery hook were not exposed.No arcing.There were no signs of thermal damage at site of the breakage.The tip separated, making cautery function impossible.There was no injury.It was reported that while the device was cauterizing the tissue, there were coating peeling.There was no separation, but the tip appeared to weaken, exhibiting a movement similar to wobbling.Ultimately, the tip detached while removing the instrument from the 5x250 cannula, rendering it unusable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.

• 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: 24750914
• Report Number: 2955842-2026-20023
• Device Sequence Number: 13333573
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)250102(10)K10250102
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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): 05/19/2026

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: K10250102 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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