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

Model Number	470056-11
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the 0-deg endoscope plus had a broken tip.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The endoscope plus has been returned and evaluated by the failure analysis (fa) team.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.Additionally, 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.Also, 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 aea shaft bearing contributing to friction.The endoscope was visually inspected and confirmed hairline crack was found on the bezel of the button pack assembly.During inspection of the endoscope cable integrated connector, the cable integrated connector housing exhibited discoloration.The complaint was confirmed by failure analysis.

• 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 ; +1(408)523-2100
• MDR Report Key: 50813691
• Report Number: 2955842-2026-39277
• Device Sequence Number: 18815657
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• 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