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	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 0-degree endoscope plus failed self-test multiple times.Endoscope was washed and same error occurred.There is a dent on the distal end of the scope.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 were no reports by staff or the surgeon that any fragments fell into a patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 0-degree endoscope plus was analyzed and found the failed self-test issue through log review identifying "video error lost on the surgeon console", however, the failure could not be replicated during testing.Visual inspection also noted a dent on the distal end of the device.Visual inspection identified mechanical damage to the endoscope distal tip, which was not reported by the site.Visual inspection identified damage at the distal end, including a cracked distal window at the endoscope tip.Visual inspection identified distal end damage, including a broken/detached piece of the distal window that could potentially fall into the patient.Functional testing identified an image artifact in the right eye, which was not reported by the site.Functional testing identified an image artifact in the left eye during light leakage testing, which was not reported by the site.Additionally, failure analysis identified the camera module failed internal diagnostic testing following disassembly and evaluation, which was not reported by the site.The complaint was confirmed by failure analysis.The probable root cause of detached fragment is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.

• 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: 50216075
• Report Number: 2955842-2026-35263
• Device Sequence Number: 6098178
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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