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

Model Number	420184-15
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted multi vessel tcab surgical procedure, the permanent cautery spatula instrument smoked around the robotic arm.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Analysis is in progress.A follow-up mdr will be submitted when the instrument is evaluated and/ or if additional information is received.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The permanent cautery spatula instrument has been returned and evaluated by the failure analysis (fa) team.Fa was not able to confirm nor reproduce the reported complaint.The instrument was placed and driven on an in-house system.The instrument fired as expected.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The instrument was fully functional.No product issue was identified, and the product is considered conforming in its current state.

• 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 ; 4085232100
• MDR Report Key: 19218082
• Report Number: 2955842-2024-13857
• Device Sequence Number: 6961234
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)K11230627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 420184-15
• Device Catalogue Number: 420184
• Device Lot Number: K11230627 762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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: Reuse
• 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