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

Model Number	470184-13
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the permanent cautery spatula instrument tip was damaged.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no report of material broken off or detached.There was the location that looked a slight crack or scratch on the tip.There were no noticeable defects with the cable.No photographic images of the instrument available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the permanent cautery spatula instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley at the monopolar yaw pulley.Material appears to have burnt off from the charring that occurred at the yaw pulley.The instrument failed the electrical continuity test.Components adjacent to the yaw pulley do not show thermal damage.The probable root cause of the thermal damage is primarily attributed to the use conditions of monopolar energy if the lowest power or effect setting possible is not used for the minimum time necessary to achieve the desired effect.If this instrument has thermal damage but no damage to the conductor wire and/or ceramic sleeve, then this damage is the result of capacitive coupling, which is the transfer of electrical energy between two conductive materials that are separated by intact insulation.Capacitive coupling from the distal electrode should be detectable by the user as the distal electrode should always be visualized when energy is activated.

• 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 ; 4085232100
• MDR Report Key: 25352532
• Report Number: 2955842-2026-27141
• Device Sequence Number: 10668936
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N10200121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470184-13
• Device Catalogue Number: 470184
• Device Lot Number: N10200121 0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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
• Patient Sex: Unknown