MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC None; ENDOSCOPE PLUS

Model Number	470057-11
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.Isi followed up with the initial reporter and obtained the following additional information: central processing department identified a crack on the tip of the endoscope during inspection.The endoscope was removed from service and not used on a patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The endoscope plus instrument was analyzed and found with damage at the distal end.The distal window located at distal tip was visually inspected and found cracked.Additionally, the endoscope was visually inspected and damage was found at the distal end.The distal window located at the distal tip was visually inspected and found to have a broken or detached piece in a location that could fall into the patient.The endoscope was tested and placed on in-house system for functional testing and failed to provide a video due to an electrical communication failure.The in-house system or equivalent failed to communicate with the endoscope, resulting in an error message: check endoscope cable connection/endoscope self - test failed.The endoscope was visually inspected and found with mechanical damage the scope¿s distal tip.The endoscope was tested and placed on in-house system for functional testing and failed to endoscope diagnostic test (edt) not recognize.The endoscope was evaluated and found with a camera instrument adapter defect.The endoscope was placed through friction test using a screening aide to manually rotate the adapter to detect for friction.The camera instrument adapter did not rotate properly and/or noises were heard during testing and confirmed as binding.The camera instrument adapter removed from endoscope housing and evaluated and found with attached endoscope adapter (aea) shaft bearing contributing to friction.The endoscope was tested and place on an in-house system for cable testing and failed due to wpb defect.The probable root cause of the cracked lens is attributed to use conditions 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.

• Brand Name: None
• Common Device Name: ENDOSCOPE PLUS
• 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 ; +1(408)523-2100
• MDR Report Key: 50877577
• Report Number: 2955842-2026-39735
• Device Sequence Number: 15758999
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191736
• 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
• Report Date (Section B): 09/23/2026

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: 470057-11
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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