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

Model Number	470056-11
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing procedure, the 0-degree endoscope plus was found to have a distal tip broken.The customer reported event had no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the tip was broken outside the or, not anywhere near the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 0-degree endoscope plus to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The endoscope was visually inspected and found cosmetic damage.During inspection, the distal tip of the endoscope is broken.The probable root cause of the problem of aesthetic damage to the camera instrument is usually attributed to use conditions, such as improper reprocessing.Additional observations not reported by site: 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 probable root cause of the camera instrument: distal cracked window is usually attributed to use conditions, such as inadvertent collisions with hard surfaces or falling endoscope or caused by improper cleaning during reprocessing.The endoscope was visually inspected and found with cosmetic damage.During inspection of the endoscope housing, the housing shell exhibited laser marking fading and/or removed.The probable root cause is typically attributed to use conditions, such as improper reprocessing.The endoscope was visually inspected and found with cosmetic damage.During inspection of the endoscope cable integrated connector, the cable integrated connector housing exhibited discoloration.Visual inspection confirmed.The probable root cause for is typically attributed to component failure, such as material degradation.The endoscope cable integrated connector was visually inspected and found with damage.The cable integrated connector exhibited corrosion on the spring fingers.The probable root cause is typically attributed to use conditions, such as improper reprocessing.The endoscope was placed through friction test using a screening aid 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 probable root cause of this binding is attributed to component susceptibility to increased friction.The endoscope was tested and placed on in-house system or equivalent for functional testing and failed to provide a video due to an electrical or communication failure.The in-house system or equivalent failed to communicate with the endoscope, resulting in an error message.The probable root cause is not determinable/applicable.The endoscope was tested and placed on in-house system or equivalent for functional testing and failed to provide a video due to an electrical or communication failure.The system or equivalent failed to communicate with the temperature sensor located on the camera module and resulted in an error message.The probable root cause is not determinable/applicable.The endoscope was placed on an in-house diagnostic tester or equivalent and found with local button controls not working properly.The endoscope failed the button functionality test.The probable root cause is not determinable/applicable.The endoscope was tested and placed on an in-house system or equivalent for functional testing failed due to an electrical failure.The probable root cause is not determinable/applicable.Fa plus - observations: the endoscope was tested and place on an in-house system for cable testing and failed due to wahoo paddle board (wpb) defect.

• 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: 25573030
• Report Number: 2955842-2026-29236
• Device Sequence Number: 13002920
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2026

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: 470056-11
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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