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	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a microlaryngoscopy - vocal cords procedure the tip of the fiber broke off after 12 minutes of use in cw mode with 5watts.The physician was able to retrieve the tip and completed the procedure with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection under microscope, showed that the fiber tip appeared to have been used, and showed remnants associated with a breakage or cracking.The reported event is confirmed based on this device finding.There were no obvious damages to the fiber body or connector.During functional testing the fiber was attached to a light source.The testing conducted showed energy transfer through to the tip.Only minor imperfections associated with use were identified.The device history record confirmed that the fiber met specification prior to release.Based on device analysis and information available, it is probable that physician technique, size and composition of the material being ablated, may have contributed to the observed fiber tip damage.According to the device instructions for use (ifu), it is indicated that 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.
Event or Problem Description
It was reported that during a microlaryngoscopy - vocal cords procedure the tip of the fiber broke off after 12 minutes of use in cw mode with 5watts.The physician was able to retrieve the tip and completed the procedure with another of the same device.There were no patient complications.
Event or Problem Description
It was reported that during a microlaryngoscopy - vocal cords procedure the tip of the fiber broke off after 12 minutes of use in cw mode with 5watts.The physician was able to retrieve the tip and completed the procedure with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection under microscope, showed that the fiber tip appeared to have been used, and showed remnants associated with a breakage or cracking.The reported event is confirmed based on this device finding.There were no obvious damages to the fiber body or connector.During functional testing the fiber was attached to a light source.The testing conducted showed energy transfer through to the tip.Only minor imperfections associated with use were identified.The device history record confirmed that the fiber met specification prior to release.Based on device analysis and information available, it is probable that physician technique, size and composition of the material being ablated, may have contributed to the observed fiber tip damage.According to the device instructions for use (ifu), it is indicated that 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.

• Brand Name: FIBERLASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16935555
• Report Number: 2124215-2023-23809
• Device Sequence Number: 17985943
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2023

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: 0003400922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 09/21/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/03/2023; 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• 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