MAUDE Adverse Event Report: LUMENIS LTD FIBERLASE ENDURE CO2 FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	AC-1148110
Medical Device Problem Codes	Melted (1385); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the end of a procedure, the insulation fiber part, approximately 30cm from the proximal part of the fiber, had melted.The procedure was completed with original fiber without patient complications.
Additional Manufacturer Narrative
B3.Date of event the exact date of the event is unknown, estimated.
Additional Manufacturer Narrative
B3.Date of event the exact date of the event is unknown, estimated.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber tip was in good condition, therefore, the initial allegation was not confirmed.However, the investigation analysis did find that the fiber jacket was melted towards the connector end.Also, the fiber body was bent/kinked, and the aiming beam was exiting from that area.The fiber kink area likely developed due to procedural conditions during device setup or use.The customer reported the damage near the end of the procedure.With the fiber bent, the laser energy exited at the damaged site, causing localized overheating and melting of the fiber jacket.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.According to the device instructions for use (ifu): the first 30 cm of fiber must remain straight during laser use.Failure to do this may diminish power delivery and cause the fiber to overheat and burn, resulting in possible stray laser energy and inspect the full length of the fiber for kinks, punctures, fractures or other damage.Do not use if the fiber appears to be damaged.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that at the end of a procedure, the insulation fiber part, approximately 30cm from the proximal part of the fiber, had melted.The procedure was completed with original fiber without patient complications.

• Brand Name: FIBERLASE ENDURE CO2 FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23802436
• Report Number: 2124215-2025-90767
• Device Sequence Number: 9333889
• Product Code: GEX
• UDI-Device Identifier: 07290109142081
• UDI-Public: (01)07290109142081(17)280922(10)14211023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: AC-1148110
• Device Catalogue Number: AC-1148110
• Device Lot Number: 0014211023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown