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	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer reinstalled the 0-degree endoscope plus to clear the issue.Technical support engineer (tse) advised that to avoid this, the customer needs to remove the endoscope from arm, rotate endoscope base until the correct orientation, press the clutch button on the arm that was holding the endoscope (to cancel guided scope change), and reinstall the endoscope onto the arm.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.The probable root cause is attributed to improper customer setup.Based on tse notes, the system issue was due to an improperly seated endoscope.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the endoscope orientation issue occurred, causing the image to flip twice.Before contacting technical support, the endoscope was reinstalled and the issue was resolved.System logs were reviewed, but no errors or failures associated with this behavior were found.The troubleshooting process included advising steps for correcting orientation and preventing recurrence.The procedure was completing as planned with no reported injury.

• 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 ; 4085232100
• MDR Report Key: 25233521
• Report Number: 2955842-2026-25466
• Device Sequence Number: 10238539
• Product Code: NAY
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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: Male