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

Model Number	470056-11
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found with damage at the distal end.The distal window located at distal tip was visually inspected and found cracked.Additional observation(s) 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 endoscope was visually inspected and found with mechanical damage to the scope¿s distal tip.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 endoscope cable connector was visually inspected and found with costumer labels/marks.During inspection of the endoscope cable connector, the housing exhibited customer labels or marking added.The endoscope cable connector was visually inspected and missing electrical contacts were found on the paddleboard.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 complaint was confirmed by failure analysis.The probable root cause of the cracked lens is attributed to damage during use or improper handling.Accidental drops of the endoscope, inadvertent collisions with hard surfaces, or improper cleaning during reprocessing can result in damaged optical components.A cracked window can also result in fluid invasion that may further the damage to optical components.
Event or Problem Description
It was reported that the 0-degree endoscope plus was defective but not additional information was provided.There was no report of patient involvement or no reported injury.

• 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: 25226043
• Report Number: 2955842-2026-25746
• Device Sequence Number: 10073701
• Product Code: NAY
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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