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	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received 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 tip part of permanent cautery hook instrument was noted to be bent and upon checking, it was found that the tip part was separated.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Correction - h8 updated to indicate initial use of device.Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The permanent cautery hook (pch) instrument was analyzed and found to have a dislodged proximal clevis.The clevis is detached from the main tube.No piece is missing as the hook is still attached.The complaint regarding the tip was found to be separated was confirmed by failure analysis.The probable root cause of the broken instrument main tube and the dislodged proximal clevis is damage sustained during use, which may occur from accidental dropping of the instrument or unintended collisions with other instruments.
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: 22929009
• Report Number: 2955842-2025-36108
• Device Sequence Number: 9156794
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)240215(10)K10240215
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 478090-03
• Device Catalogue Number: 478090
• Device Lot Number: K10240215 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: Female