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

Model Number	470056-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 0-degree endoscope plus to perform failure analysis.The endoscope was visually inspected and found with mechanical damage to the scope¿s distal tip.The probable root cause is typically attributed to use conditions, such as inadvertent collisions with hard surfaces or drop of the scope.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 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 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 use conditions, such as inadvertent collisions with hard surfaces or drop of the scope 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 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 visually inspected and found with minor cuts to the cable insulation.The damage was located at zone a near integrated connector of the endoscope cable.The probable root cause is typically attributed to the user, such as improper handling of the cable during use or in reprocessing.
Event or Problem Description
It was reported that during central processing, a 0-degree endoscope plus had an issue.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the materials did not become detached inside the patient, as the scope was not used on the patient because when it was plugged in, they got an error that the right eye was not working.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.

• 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: 25369739
• Report Number: 2955842-2026-27312
• Device Sequence Number: 16089996
• 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): 06/02/2026

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: 470056-08
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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