MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; CANNULA, FLARED, GROUNDED, REUSABLE

Model Number	470319-06
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A review of the site's system logs for the reported procedure date was conducted and the investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that after a da vinci-assisted oropharyngectomy procedure, a burn injury was observed on the patient's lip.The monopolar curved scissors (mcs) instrument had been used in the area where the injury occurred.The surgeon speculated that the patient's lips may have come into contact with the flared cannula during the procedure, as no other instruments contacted the lips.The burn was classified as first-degree, appearing red without bruising or charring.Burn ointment was applied, and no further intervention, such as tissue excision, was necessary.The exact cause of the incident remains unknown, including whether arcing occurred during the procedure.All instruments and the flared cannula were inspected and there was no damage or abnormalities observed.The patient did not experience any other post-operative complications and has since been discharged.

• Brand Name: DA VINCI
• Common Device Name: CANNULA, FLARED, GROUNDED, 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: 22766642
• Report Number: 2955842-2025-33623
• Device Sequence Number: 15632621
• Product Code: NAY
• UDI-Device Identifier: 00886874112458
• UDI-Public: (01)00886874112458(10)VE224303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 470319-06
• Device Catalogue Number: 470319
• Device Lot Number: VE224303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• 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