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	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure with this fiber, the tip fell off inside the patient, and it had to be retrieved with a forceps during the procedure.Another fiber was used to complete the procedure.
Event or Problem Description
It was reported that during a procedure with this fiber, the tip fell off inside the patient, and it had to be retrieved with a forceps during the procedure.Another fiber was used to complete the procedure.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this fiber underwent a thorough analysis, where it was visually and microscopically examined.No anomalies were found with the visual examination as the fiber body did not exhibit any break and it was received in one piece.Microscopic inspection of the tip revealed that the tip was broken.There was no indication in the complaint that the product was not used in accordance to the labeling.The instructions for use state: the co2 laser fiber is designed to be used in non-contact mode.Keep inadvertent contact between the fiber tip and tissue to a minimum.Firing the laser when the fiber is in contact with the tissue will damage the tip and may cause it to break off.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip break.Based on the information available and analysis results, it was possible to confirmed the reported clinical observation.

• 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): LUMENIS LTD.; hakidma st 6; yokneam industrial park; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20678309
• Report Number: 2124215-2024-70515
• Device Sequence Number: 21122509
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 0018030524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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