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

Model Number	AC-1059590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the initial attempt to lase, the co2 fiber broke inside the patient airway.The glass tip of the fiber detached and broke off into the tissue upon insertion into the patient.The glass fragment was retrieved by the attending surgeon via suction.There were no reported patient complications.It was noted that the procedure was not completed.
Additional Manufacturer Narrative
Exact b3 date of event is unknown.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that, during the initial attempt to lase, the co2 fiber broke inside the patient airway.The glass tip of the fiber detached and broke off into the tissue upon insertion into the patient.The glass fragment was retrieved by the attending surgeon via suction.There were no reported patient complications.The procedure was completed without the use of the laser.
Event or Problem Description
It was reported that, during the initial attempt to lase, the co2 fiber broke inside the patient airway.The glass tip of the fiber detached and broke off into the tissue upon insertion into the patient.The glass fragment was retrieved by the attending surgeon via suction.There were no reported patient complications.The procedure was completed without the use of the laser.

• 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: 23986574
• Report Number: 2124215-2026-00855
• Device Sequence Number: 14610043
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: (01)07290109142012(17)300831(10)28081025
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 0028081025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/04/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/29/2026; 02/26/2026
• Date Device Manufactured: 10/01/2025
• 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: Unknown