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

Model Number	470067-18
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced an inverted image while using a 30 degree endoscope.The customer replaced the endoscope and finished the procedure without further issue.The technical support engineer (tse) reviewed the system logs and found no associated errors.The tse provided troubleshooting guidance to correct an inverted 30 degree endoscope orientation by removing the scope from the arm, rotating the endoscope base until the correct orientation indicator (30 degree up, 30 degree down) appeared on the display, pressing the clutch button on the arm to cancel guided scope change, and reinstalling the endoscope.The customer planned to retest the suspect endoscope and pursue return of the device if the issue persisted.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the endoscope base was not damaged.The customer noted that the endoscope was manually rotated prior to the issue, the surgeon did not manually associate the right and left controls with the respective arms.The customer clarified that the endoscope would not be returned as it was operating correctly after the issue was resolved.
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 replaced the 30-degree endoscope and completed the procedure without further issue.The technical service engineer (tse) advised that if the image appeared inverted while using a 30-degree endoscope, the issue could be resolved by removing the endoscope from the arm and rotating the endoscope base until the correct orientation was displayed on the screen.The clutch button on the arm that was holding the endoscope should then be pressed to cancel the guided scope change, followed by reinstalling the endoscope back onto the arm.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

• 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: 50194271
• Report Number: 2955842-2026-34941
• Device Sequence Number: 9915427
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 470067-18
• Device Catalogue Number: 470067
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• 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