MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number	470027-64
Medical Device Problem Codes	Image Orientation Incorrect (1305); Output Problem (3005)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse attempted to use the endoscope camera but was unable to reproduce the problem.Upon review of the system logs, a possible error was identified.All relevant testing was performed and all 4 universal surgical manipulators (usm) passed.The fse inspected the base of the endoscope camera and found that there was significant resistance and a slight friction noise during rotation.Based on review of the relevant information and the on-site evaluation, the fse determined that the endoscope camera had malfunctioned.The system was tested and verified as ready for use.Isi has received the 30 degree endoscope camera to perform failure analysis.However, as of the date of this report, the evaluation has not been completed.
Event or Problem Description
It was reported that during a da vinci-assisted procedure, an error occurred, resulting in the reversal of the endoscope camera image.This incident led to a laceration of an unspecified blood vessel.The issue was resolved, though specific details of the resolution were not provided, and the endoscope camera was replaced with a backup.The procedure was completed robotically without further complications.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2, h3, h6, h11.Device evaluation: intuitive surgical, inc.(isi) has received the 30 degree endoscope camera to perform failure analysis.The endoscope's shaft circularity was tested using a go-no-go gauge and failed.The gauge failed to slide smoothly down scope's shaft due to damage found at tip or shaft.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI
• 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: 25070770
• Report Number: 2955842-2026-23385
• Device Sequence Number: 21504276
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171426
• 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,Followup
• Report Date (Section B): 05/29/2026

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?: No
• 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
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/31/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown