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

Model Number	470183-19
Medical Device Problem Codes	Arcing (2583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/24/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy procedure, a minor burn injury was observed on the inside of the patient¿s abdomen at the trocar site where the permanent cautery hook (pch) instrument was used.The injury was assessed as a first-degree burn with a black, charred appearance.No bleeding was observed, and the surgeon did not provide additional treatment.The procedure was successfully completed robotically.The patient had no postoperative complications, and there is no concern for long-term complications related to this event.The patient was discharged the following day without further issues.The surgeon was unable to determine the cause and reported no observed evidence of arcing during the procedure, but noted a potential contribution from the pch instrument, green cable, or erbe generator.No damage or abnormalities were identified on the instruments or accessories.An erbe vio dv generator was used with settings of 3 for monopolar cut/coag and bipolar coag.The grounding pad was inspected prior to use; no defects or abnormalities were identified, and it was properly placed on the patient¿s left thigh.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the permanent cautery hook (pch) instrument to perform failure analysis.A review of the customer-provided image shows that the tissue does appear to be desiccated; however, the source or cause of the burn could not be determined.

• Brand Name: EndoWrist
• 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 ; +1(408)523-2100
• MDR Report Key: 50885299
• Report Number: 2955842-2026-39823
• Device Sequence Number: 13209456
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)K12251204
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470183-19
• Device Catalogue Number: 470183
• Device Lot Number: K12251204 0254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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
• Patient Weight: 400 LB