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

Model Number	470067-18
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Failure analysis investigations replicated and confirmed the customer-reported cracked lens.The endoscope was visually inspected and found to have damage at the distal end.Specifically, the distal window located at the distal tip was cracked.The root cause for a cracked distal window in the camera instrument is typically attributed to user actions, such as inadvertent collisions with hard surfaces, dropping the scope, or improper cleaning during reprocessing.Additional observations not reported by the site: the endoscope was evaluated and found to have a camera instrument adapter defect.Friction tests using a screening aide revealed that the adapter did not rotate properly, and noises confirmed binding.Upon removal and further examination, the aea shaft bearing was identified as contributing to increased friction.The probable root cause of this binding is related to component susceptibility to friction.Severe cuts to cable insulation were found during visual inspection, located in zone b, the middle third of the endoscope cable.The root cause for severe cuts in the camera cables is typically attributed to user mishandling during use or reprocessing.Cosmetic damage was observed on the endoscope housing.Inspection revealed fading or removal of laser marking on the housing shell.This issue is typically attributed to improper reprocessing by the user.Additional damage was found at the distal end, specifically a broken or detached piece of the distal window tip, presenting a potential risk of foreign body retention in the patient.The root cause is most often user-related, including inadvertent collisions, dropping the endoscope, or improper cleaning during reprocessing.
Event or Problem Description
It was reported that prior to starting a da vinci assisted surgical procedure, the lens was cracked.There was no report of patient involvement or reported injury.
Additional Manufacturer Narrative
The probable root cause of the cracked distal window and detached fragment is typically attributed to user handling, such as inadvertent collision with hard surfaces, dropping of the scope, or improper cleaning during reprocessing.This issue can be resolved by using an alternate endoscope to complete the procedure.
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: 24990465
• Report Number: 2955842-2026-22759
• Device Sequence Number: 21157260
• Product Code: NAY
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 470067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• 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: Unknown