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

Model Number	470056-12
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the image displayed on the 0 deg endoscope plus was upside down.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the site to obtain additional information: no further details could be provided regarding the reported event, other than the team reporting the image was inverted.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 0 degree endoscope plus was analyzed, and the findings did not replicate or confirm the customer reported complaint.The endoscope camera instrument adapter showed mechanical damage in the attached endoscope adapter (aea), including a stuck bearing gear.The endoscope cable integrated connector was visually inspected and found with mechanical damage.The cable integrated connector ferrule exhibited mechanical damages such as scratch marks, indentations or broken or missing pieces located at cable connector proximal end.The endoscope was visually inspected and found with minor cut(s) to the cable insulation.The endoscope was tested and placed on an in-house system for cable testing and failed due to wahoo paddleboard (wpb) defect.

• 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 ; +1(408)523-2100
• MDR Report Key: 50199512
• Report Number: 2955842-2026-35166
• Device Sequence Number: 5507565
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 470056-12
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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