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

Model Number	470184-16
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Codes	Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted uvulopalatopharyngoplasty procedure, the permanent cautery spatula (pcs) instrument was in use when the patient sustained an injury to the right soft palate.The incident occurred while the surgeon was performing the tongue base resection.At that point, the pcs instrument tip was oriented upward toward the tongue base, while the ¿wrist¿ portion of the pcs instrument was positioned near the soft palate.It is suspected that the insulated black energy wire was exposed, resulting in unintended energy discharge to the soft palate tissue.Although the bleeding was minimal, it was attributable to this event.There was no significant blood loss; however, the tissue sustained a degree of thermal injury/burn.The affected tissue was sutured and surgiseal was applied.The procedure was completed robotically, and no postoperative complications were reported.The surgeon expressed concern for potential long-term effects, including dysphagia and altered taste.The patient has been discharged and is being followed with weekly outpatient visits.An erbe vio dv generator was used during the procedure with settings of monopolar coag 2 and bipolar soft coag 3.The grounding pad was inspected prior to use, with no abnormalities noted, and was appropriately placed on the patient¿s trunk.Per the surgeon, the cause of the injury was attributed to insulation damage on the wire near the wrist, creating an unintended energy exit point other than the tip of the pcs instrument.Staff did not observe visible arcing.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the permanent cautery spatula (pcs) instrument to perform failure analysis; however, the evaluation has not been completed at the time of this report.A review of the customer-provided images show that a thermal injury occurred to the patient¿s mouth/throat tissue and was repaired with sutures.In the image of the pcs instrument, darkening is visible on the plastic wrist material; however, it is unclear whether this represents carbonized tissue or damage to the material itself.Based on the images provided, a root cause cannot be confirmed.

• 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: 50913513
• Report Number: 2955842-2026-40099
• Device Sequence Number: 5776917
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(11)250602(10)K10250602(91)0001
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470184-16
• Device Catalogue Number: 470184
• Device Lot Number: K10250602 0021
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: Required Intervention
• Patient Sex: Unknown