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

Model Number	470027-64
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the endoscope involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical low anterior resection (lar) procedure, the customer informed the technical support engineer (tse) their endoscope image was inverted after power cycling the system.The tse found no related errors.The tse had the customer remove the endoscope from the arm and clear the guided tool change with the port clutch.The customer reinstalled the endoscope and the image orientation was then correct.The customer continued with system use.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the nurse informed the surgery was low anterior resection.The 30-degree endoscope was installed.It was unknown if the scope was installed upside down.The surgeon did confirm desired orientation when endoscope was installed.The indicator on screen stated down but image was up.It was unknown if the endoscope and endoscope¿s adapter/base still engaged/in-synch/attached.There was no damage observed on the scope.It was unknown if prior to start of the scope was rotated 180 degrees.There was no patient injury.There was no recording of the scope issue.Procedure continued without incident to conclusion.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 30-degree endoscope for failure analysis investigation.The unit was analyzed and placed on a diagnostic tester or equivalent for functional testing.The light leakage test or equivalent was performed to detect if any image quality defect were detected in either or both eyes.The endoscope was found with an artifact in left.This endoscope is no longer repaired and shall be scrapped.The probable root cause of the image artifact is attributed to damage during use or improper handling.Accidental drops of the endoscope or inadvertent collisions with hard surfaces can result in damaged optical components.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22155449
• Report Number: 2955842-2025-22675
• Device Sequence Number: 7421874
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 470027-64
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White