MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number	470056-08
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope plus was analyzed and the complaint was not confirmed by failure analysis.Additional observations not reported by the site: the endoscope was evaluated on a diagnostic tester for functional testing.During the light leakage test, an image artifact was detected in the right eye.Visual inspection identified mechanical damage to the distal tip and additional damage at the distal end.The distal window was found to be cracked and contained a broken or detached piece in a location that could potentially dislodge into the patient.The button pack assembly exhibited damage, with hairline cracks observed on the left and right sides.Cosmetic damage was also noted.Inspection of the cable integrated connector confirmed discoloration of the connector housing.Further investigation was performed and the endoscope was disassembled, and the camera module was visually inspected and tested using an internal tester.The camera module failed functional testing due to a no image condition.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, customer found the 0-degree endoscope plus would not communicate with system.The procedure was completed with no reported injury.

• Brand Name: DA VINCI
• 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: 25672807
• Report Number: 2955842-2026-30756
• Device Sequence Number: 21434195
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 470056-08
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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