MAUDE Adverse Event Report: SCHOELLY FIBEROPTIC GMBH NIR HANDHELD CAMERA; CAMERA SYSTEM, NIR FI LIGHT SOURCE

Model Number	470655-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has received the nir handheld camera to perform failure analysis; however, the evaluation is still in process.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that the customer experienced visible burn marks on the near infrared (nir) handheld camera head.No known impact or patient consequence was reported.

• Brand Name: NIR HANDHELD CAMERA
• Common Device Name: CAMERA SYSTEM, NIR FI LIGHT SOURCE
• Manufacturer (Section D): SCHOELLY FIBEROPTIC GMBH; robert-bosch-strasse 1-3; denzlingen 79211 ; GM 79211
• 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: 24646131
• Report Number: 2955842-2026-16592
• Device Sequence Number: 9919007
• Product Code: GCJ
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 470655-01
• Device Catalogue Number: 470655
• Device Lot Number: 470655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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