MAUDE Adverse Event Report: Stryker Endoscopy-San Jose FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM; confocal optical imaging

Catalog Number	0233050400
Medical Device Problem Codes	Overheating of Device (1437); Electrical Shorting (2926)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that light cable did not turn off when adapter/scope was removed causing a burn on the patient.First degree burn to patient.

• Brand Name: FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM
• Common Device Name: confocal optical imaging
• Manufacturer (Section D): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25248513
• Report Number: 0002936485-2026-00322
• Device Sequence Number: 9597383
• Product Code: OWN
• UDI-Device Identifier: 07613327462777
• UDI-Public: (01)07613327462777
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0233050400
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 08/20/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/29/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown