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

Model Number	470656-01
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the handheld camera light guide cable for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.The provided images are consistent with the allegation of a burned cable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the light cord for the near infrared (nir) handheld camera got really hot.The caller mentioned that at the end of the case, there was smoke coming from the light cord, and one side was completely burned.The caller was unsure how long the light was left on for, but indicated they had turned off the light cord earlier in the procedure.They informed they would take this light cord out of rotation.The procedure was completed with no reported injury.

• Brand Name: LIGHT GUIDE CABLE
• 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: 24641369
• Report Number: 2955842-2026-16574
• Device Sequence Number: 9894588
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 470656-01
• Device Catalogue Number: 470656
• Device Lot Number: N/A
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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