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

Model Number	470027-64
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the endoscope for evaluation, but evaluation has not been completed as of the date of this report.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 30-degree endoscope plus had several issues.Firstly, the signal and image were lost immediately when the camera was flipped up or down.Secondly, the surgeon experienced a delay and asynchrony.Thirdly, the information bar at the top of the system indicated that the left eye's field of view was lost.Fourthly, the screen flickered at random times during the operation.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: firstly, regarding the use of the endoscope's functions, there were no issues or error reports before this incident.Secondly, during the prostatectomy, the surgeon performed an upward-looking operation by flipping the endoscope, without any reverse operations.There were no inverted images on the video cart; instead, the field of vision was lost.Thirdly, the visual direction was not freely movable but was still under manual control.Fourthly, the endoscope could be moved freely.Fifthly, there was no physical damage, and no parts were missing or detached and entered the patient's body.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 30-degree endoscope for failure analysis investigation.The endoscope was analyzed and the complaint was not confirmed by failure analysis.Customer reported multiple issues: image and signal loss when the camera was flipped, delay and asynchrony experienced by the surgeon, loss of the left eye¿s field of view indicated on the system, and random screen flickering during the procedure.The endoscope was found to have a defect in the camera instrument adapter.During friction testing, the adapter failed to rotate properly and produced noise, indicating binding.Further evaluation revealed that the endoscope adapter shaft bearing was contributing to the friction.
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: 22138243
• Report Number: 2955842-2025-20639
• Device Sequence Number: 7122467
• 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): 05/12/2025

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
• Date Returned to Manufacturer: 05/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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: Reuse
• 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