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

Model Number	470056-11
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 30-degree endoscope plus to perform failure analysis.The endoscope was visually inspected and was found with damage at the distal end.The distal window located at distal tip was visually inspected and found cracked.The probable root cause is typically attributed to the user, such as inadvertent collisions with hard surfaces or drop of the scope or caused by improper cleaning during 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 the user, 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 cable integrated connector, the cable integrated connector housing exhibited discoloration.Visual inspection confirmed.The probable root cause is typically attributed to component failure, such as material degradation.The endoscope was visually inspected and manually tested by hand using a series of movement tests and failed.The endoscope was detected with rattling or noise from the housing and/or detected loose balls from the led windows.The endoscope was disassembled and confirmed with dislodged desiccant balls inside backend housing.The probable root cause is attributed to component susceptibility through external collisions, during use, or during reprocessing.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 probable root cause of this binding is attributed to component susceptibility to increased friction.The endoscope was evaluated and placed on a diagnostic tester or equivalent for functional testing.The light leakage test or equivalent was performed to detect if any image quality defects were detected in either or both eyes.The endoscope was found with an artifact in both eyes.The probable root cause is not determinable/applicable.The endoscope was disassembled and the camera module was visually inspected and placed on an internal tester and failed.The camera module failed imagen test.The probable root cause is not determinable/applicable.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the 0-degree endoscope plus had a crack lens.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no complaint by the staff that the lens was broken or involved in a surgical procedure.This was discovered outside of a surgery.

• 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: 25143652
• Report Number: 2955842-2026-24619
• Device Sequence Number: 9325174
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/11/2026

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: 03/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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