MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE PLUS

Model Number	470057-11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted proctectomy procedure, the 30 degree endoscope plus was left on the patient with the light turned on, causing a 2cm diameter circular burn on the patient's thigh.The endoscope remained on the patient for approximately 15-20 minutes while not in use, causing the drape covering the patient to melt and inflicting a 1st to 2nd degree burn.The burn was noted without charring, bruising, or bleeding.The only medical treatment administered was the application of burn ointment.The procedure was completed successfully, and the patient did not experience any post-operative complications.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer indicated that the endoscope light was left on and burned the patient after being on the patients thigh for 15-20 minutes.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.A review of the site¿s system logs showed no related errors.

• Brand Name: DA VINCI
• Common Device Name: ENDOSCOPE PLUS
• 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: 25233836
• Report Number: 2955842-2026-25827
• Device Sequence Number: 14219639
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 470057-11
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown