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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that prior to the start (post-anesthesia) of a da vinci-assisted tongue base resection - malignant surgical procedure, the permanent cautery spatula insulator at wrist was degraded and had burnt marks on it.The procedure was completed as planned with no reported injury using a backup instrument.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no arcing was observed during the last procedure in which the instrument was used.The type of energy activated at the time was unknown.It was also unknown if the instrument tips collided with any other instrument or tool during procedure.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery spatula instrument was analyzed and found to have localized melting on the distal clevis.The instrument was placed and driven on an in-house system.The instrument passed the recognition, engagement, energy delivery and electrical continuity tests, moved intuitively with full range of motion in all directions.Additionally, the instrument was found to have thermal damage on the monopolar yaw pulley at the distal clevis.Material appears to have burnt off from the charring that occurred near the distal clevis.The instrument passed the electrical continuity test.Components adjacent to the yaw pulley do 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.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24890058
• Report Number: 2955842-2026-21697
• Device Sequence Number: 16057456
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N10190708
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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: N10190708 0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 06/11/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/06/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2019
• 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