MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; PERMANENT CAUTERY SPATULA

Model Number	470184-17
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/25/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted supraglottic laryngectomy, energy from the permanent cautery spatula dispersed through the pulley cables, resulting in an injury to the interior of the patient's throat.The instrument had been inspected prior to use with no abnormalities observed.An arc was formed between one of the wires at the distal end of the instrument and the affected area of the throat at the time monopolar coag energy was activated.The tip of the permanent cautery spatula did not come into contact with any other instrument or tool during the procedure.The procedure was completed with a 15-30-minute delay.The injury did not result in any complications, long-term sequelae, or the need for additional intervention, and the patient recovered well.
Additional Manufacturer Narrative
Intuitive surgical, inc (isi) did not receive a da vinci product to perform failure analysis.A review of the provided image was performed, revealing two areas of thermal damage on an unidentified tissue.As only an image of the tissue was available for review, a cause determination could not be made.

• Brand Name: EndoWrist
• Common Device Name: PERMANENT CAUTERY SPATULA
• 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 ; +1(408)523-2100
• MDR Report Key: 50867261
• Report Number: 2955842-2026-39656
• Device Sequence Number: 9314534
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)K10260122
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131861
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470184-17
• Device Catalogue Number: 470184
• Device Lot Number: K10260122 0079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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: Other
• Patient Sex: Unknown