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	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, user informed the technical support engineer (tse) that the orientation of the 30-degree endoscope appeared to differ from the vision side cart (vsc) image by about 90 degrees, and reinstalling the sterile adapter and endoscope did not improve the issue.The user confirmed that the image was not the known condition where the 30-degree scope orientation was flipped and the image appeared upside down.The user continued the procedure without issue and planned to perform additional testing after the procedure.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported event was addressed with phone support.The technical support engineer (tse) recommended testing with another 30-degree endoscope or restarting the system.The customer stated that the procedure could continue without issue and planned to perform the recommended troubleshooting after the procedure.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.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: 50806152
• Report Number: 2955842-2026-39064
• Device Sequence Number: 10549050
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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