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

Model Number	420184-15
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer noticed sparks coming from the permanent cautery spatula instrument insulation of the electrocautery tip while clearing pelvic lymph nodes.The procedure was completed with no reported injury.The arcing appear to originate/occur from equipment, wrists, insulating materials and places.The arc grounded on patient anatomy when the monopolar coag energy was activated.Burnt insulation was noticed on the instrument.The instrument tips did not collide with any other instrument or tool during procedure.It was reported that there was no injury to the patient.The procedure was completed as planned.
Additional Manufacturer Narrative
The permanent cautery spatula instrument has not been received for investigation.The video of this procedure was reviewed.From the video alone, it is not possible to determine if any arcing, sparks or burnt insulation were present.In the video, the operator is dissecting tissue using the monopolar cautery spatula while retracting locally with the fenestrated forceps.The tip of the spatula is removed from tissue contact then the wrist of the instrument rests against the tissue where some heat appears to be generated along with smoke.The wrist is rolled, making tissue contact again, generating heat and smoke once again.No arcing was confirmed from the video.

• Brand Name: EndoWrist;daVinci Si
• 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: 50931441
• Report Number: 2955842-2026-40266
• Device Sequence Number: 9563556
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• 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): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 420184-15
• Device Catalogue Number: 420184
• Device Lot Number: K10250529 857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown