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

Model Number	AC-1059590
Medical Device Problem Codes	Melted (1385); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laryngoscopy procedure, there were two fibers used not working, as the fiber tip was melted.The procedure was completed with a third fiber without patient complications.
Event or Problem Description
It was reported that during a laryngoscopy procedure, there were two fibers used not working, as the fiber tip was melted.The procedure was completed with a third fiber without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber had no defects and the functional test found that the aiming beam was dim.The microscope analysis did find that the fiber tip was damaged and burnt out, therefore, the complaint was confirmed.It appears likely that procedural conditions, physician technique, size and composition of the material being ablated, may have contributed to the fiber tip damaged and melted.Due to the damaged fiber tip, that could lead to a diminish energy exiting the fiber.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.According to the device instructions for use (ifu): there are several ways to deliver the fiber tip to the treatment site.It can be inserted into a handpiece, for handheld use as well as insertion through the hollow channel of an endoscope; several rigid and malleable configurations are available.When working with flexible endoscopes, the fiber should be inside the fiberlase endoscope protection sheath, in order to protect the flexible material which lines the lumen.Placing the fiber in the fiberlase robotic drop-in guide enables the robot to be used to guide the tip.The fiber should never be held with bare hands during use.The fiberlase co2 fiber is intended for use in non-contact mode.If the tip is damaged during surgery, it can be quickly repaired using the fiberlase fiber renewal kit (see instructions on procedure for renewal of the fiberlase fiber tip section).Firing the laser when the fiber tip and/or aiming beam is not in clear view may result in damage to non-target tissue and may cause inadvertent damage to the fiber, endoscope or patient.Based on the analysis performed, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: FIBERLASE
• 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: 23671872
• Report Number: 2124215-2025-83883
• Device Sequence Number: 21259736
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: (01)07290109142012(17)300802(10)27500925
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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-1059590
• Device Catalogue Number: AC-1059590
• Device Lot Number: 0027500925
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female