MAUDE Adverse Event Report: LUMENIS, LTD. FiberLase¿ CO2 Fiber; Powered Laser Surgical Instrument

Model Number	FiberLase¿ CO2 Fiber
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Burn mark to mouth/lip/face resulting from break in laser fiber - heating up the metal rigid bronchoscope.

• Brand Name: FiberLase¿ CO2 Fiber
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): LUMENIS, LTD.; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 50753892
• Report Number: 50753892
• Device Sequence Number: 9668034
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: (01)07290109142012(17)280715(10)12930823
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/30/2026
• Report Date (Section F): 07/30/2026

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
• Device Model Number: FiberLase¿ CO2 Fiber
• Device Catalogue Number: AC-1059590
• Device Lot Number: 12930823
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/30/2026