MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; NIR HANDHELD CAMERA (SCHOELLY OEM 95-390)

Model Number	470655-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, there was an issue with the near infrared (nir) handheld camera.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the da vinci coordinator confirmed that the following information was related to the nir handheld camera.The lens was broken/fell out of the scope after the procedure in the sterile processing department.The procedure was completed robotically.There was no injury or complications to the patient.
Additional Manufacturer Narrative
A return material authorization (rma) had been issued requesting to have the isi device returned; however, intuitive surgical, inc.(isi) did not receive the rma to confirm/identify the failure mode.
Additional Manufacturer Narrative
The near infrared (nir) handheld camera was not tested by intuitive surgical, inc.(isi) and it was returned to the supplier.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: NIR HANDHELD CAMERA (SCHOELLY OEM 95-390)
• 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: 24961846
• Report Number: 2955842-2026-22608
• Device Sequence Number: 4991765
• Product Code: GCJ
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K221591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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