MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; NIR HANDHELD CAMERA

Model Number	470655-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nir handheld camera had a unknown issue.There was no report of patient involvement or reported injury.
Additional Manufacturer Narrative
An investigation is pending to determine the cause of this reported event.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

• Brand Name: NONE
• Common Device Name: NIR HANDHELD CAMERA
• 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: 24262864
• Report Number: 2955842-2026-03187
• Device Sequence Number: 10059005
• Product Code: GCJ
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 470655-01
• Device Catalogue Number: 470655
• Device Lot Number: 470655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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