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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, an endoscope plus 30 degrees rotated with the view facing upward, the image was inverted.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive endoscope plus to perform failure analysis.The endoscope was placed through friction test using a screening aid to manually rotate the adapter to detect for friction.It was found to have an attached endoscope adapter (aea) bearing friction issue.The camera instrument adapter did not rotate properly and/or noises were heard during testing and confirmed as binding.Additionally, the endoscope was visually inspected and found with damage to the button pack assembly.Also, the endoscope was visually inspected and found with cosmetic damage.Moreover, the endoscope cable integrated connector was visually inspected and found with the board exhibited missing electrical contacts.The complaint was confirmed by failure analysis.The probable root cause is attributed to component susceptibility to increased friction.

• 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: 50852013
• Report Number: 2955842-2026-39591
• Device Sequence Number: 18530097
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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