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

Model Number	AC-1059590
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber did not fire.The fiber was replaced, but the second fiber did not fire either.The procedure was completed with a different device.Analysis of the returned device identified a fracture on the tip of the fiber.There were no patient complications.This complaint refers to the second fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis did not identify any defects.Microscopic inspection of the tip identified that the tip is fractured.It is likely that the fiber stopped working as the tip is fractured.Procedural handling of the device during post cleaning, set-up or use, may have contributed to the fiber tip break.According to the instructions for use (ifu), 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.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis did not identify any defects.Microscopic inspection of the tip identified that the tip is fractured.It is likely that the fiber stopped working as the tip is fractured.Procedural handling of the device during post cleaning, set-up or use, may have contributed to the fiber tip break.According to the instructions for use (ifu), 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 the fiber did not fire.The fiber was replaced, but the second fiber did not fire either.The procedure was completed with a different device.Analysis of the returned device identified a fracture on the tip of the fiber.There were no patient complications.This complaint refers to the second fiber.

• 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: 16549789
• Report Number: 2124215-2023-12047
• Device Sequence Number: 6043179
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 0094020622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female