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

Model Number	470056-11
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
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 zero degree endoscope plus was observed as needing repair the procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The zero (0) degree endoscope plus was analyzed and found with damage to the distal end, including a cracked distal window at the distal tip and a broken or detached piece that could fall into the patient.Mechanical damage to the distal tip was also observed.The endoscope cable connector exhibited customer-added labels or markings.The endoscope underwent friction testing using a screening aid to manually rotate the adapter and detect friction; the camera instrument adapter did not rotate properly, noises were heard during testing, and binding was confirmed.The endoscope cable was visually inspected and found with a defect at zone c near the endoscope housing.Visual inspection confirmed visible light shining through the cable insulation jacket when the cable was connected to the internal system (or equivalent) and illumination was powered on.The complaint regarding the instrument needed repair was confirmed by failure analysis.The probable root cause can be attribute to conditions during user, such as inadvertent collisions with hard surfaces or falling endoscope or caused by improper cleaning during reprocessing.

• 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: 50767493
• Report Number: 2955842-2026-38943
• Device Sequence Number: 15806312
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 08/05/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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