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

Model Number	470026-64
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the 0-degree endoscope plus had a broken lens.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have damage at the distal end.The distal window located at the distal tip was visually inspected and found cracked.The endoscope was visually inspected and found to have cosmetic damage.During inspection of the endoscope cable integrated connector, the cable integrated connector housing exhibited discoloration.The complaint was confirmed by failure analysis.The probable root cause of the cracked lens is attributed to damage during use or improper handling.Accidental drops of the endoscope, inadvertent collisions with hard surfaces, or improper cleaning during reprocessing can result in damaged optical components.A cracked window can also result in fluid invasion that may further the damage to optical components.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 23529869
• Report Number: 2955842-2025-44837
• Device Sequence Number: 18648547
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 470026-64
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/12/2025
• 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 Sex: Unknown