MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC None; ENDOSCOPE PLUS

Model Number	470057-12
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted single internal mammary artery harvest surgical procedure, user informed the technical support engineer (tse) that the endoscope image orientation appeared incorrect, and they power cycled the system to resolve the issue.The tse reviewed the logs and did not find any related issues, then asked whether the scope flipping feature was used; the user stated it was used but it did not work.The tse explained that the system retained memory related to the endoscope and advised canceling the guided tool change in the future instead of power cycling to address the orientation issue.The user continued with the procedure using the same system configuration with no further issues.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.

• Brand Name: None
• Common Device Name: ENDOSCOPE PLUS
• 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 ; +1(408)523-2100
• MDR Report Key: 50751673
• Report Number: 2955842-2026-38837
• Device Sequence Number: 10367214
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 470057-12
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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