MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470066-13
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zero degree endoscope has been returned and evaluated by the failure analysis (fa) team.The endoscope was tested and placed on an in-house system or equivalent for functional testing, but it failed to provide a video due to an electrical or communication failure.The endoscope was plugged on in-house system or equivalent and provided color bars in both eyes.Additionally, the endoscope cable integrated connector was visually inspected and found to be damaged.The endoscope cable integrated connector was visually inspected and found to be damaged.The endoscope was visually inspected and found to have damage to the button pack assembly.Visual inspection confirmed a hairline crack on the illuminator of the button pack assembly.The endoscope was visually inspected and was found to have damage at the distal end.The distal window located at the distal tip was visually inspected and found cracked.The endoscope was visually inspected and was found to have damage at the distal end.The distal window located at the distal tip was visually inspected, and a detached fragment was found.The endoscope camera module was disassembled for visual inspection and found with capacitors and inductor damage.The endoscope was tested after changing the cable for a known good cable into a test fixture, then a functional test to verify electrical/communication performance, and it failed of vision in both eyes.The endoscope tip was cut for visual inspection of the camera module, and damage was found on the component of the u3 siliconline mipi-to-serial capacitor (c12), which may cause the failure.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the 8mm endoscope, 0° had a fault 45312 "loss of the right eye".The procedure was completed with no reported injury.Intuitive followed up with the initial reporter and obtained the following additional information: no fragments fall into the patient's body.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 24736203
• Report Number: 2955842-2026-19797
• Device Sequence Number: 18747253
• Product Code: NAY
• UDI-Device Identifier: 00886874120293
• UDI-Public: (01)00886874120293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 470066-13
• Device Catalogue Number: 470066
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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