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

Model Number	AC-1059590
Medical Device Problem Codes	Melted (1385); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the coating around the fiber began to dissolve and there was an unusual odor.The coated surface of the fiber melted at the proximal part of the fiber.The procedure was continued and completed with the same fiber.There were no patient injuries reported.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified a body break between the connector and the tip; therefore, the reported event is confirmed.It is likely that the fiber could have had a microfracture and when it was connected to the console, it caused the fiber to overheat leading to the separation of the fiber body from the connector.Visual examination also identified the fiber jacket to have severe burn marks and melting.It is likely that energy leak through the fracture could have leaded into the melted jacket.Based on all information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the coating around the fiber began to dissolve and there was an unusual odor.The coating/surface of the fiber melted at the proximal part of the fiber.The procedure was continued and completed with the same device.There were no patient injuries reported.Additional information received stating that the coating/surface of the fiber melted at the proximal part of the fiber, and the odor came from the melted part of the fiber.There was no issue reported with the console system that was used with the fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified a body break between the connector and the tip; therefore, the reported event is confirmed.It is likely that the fiber could have had a microfracture and when it was connected to the console, it caused the fiber to overheat leading to the separation of the fiber body from the connector.Visual examination also identified the fiber jacket to have severe burn marks and melting.It is likely that energy leak through the fracture could have leaded into the melted jacket.Based on all information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the coating around the fiber began to dissolve and there was an unusual odor.The coating/surface of the fiber melted at the proximal part of the fiber.The procedure was continued and completed with the same device.There were no patient injuries reported.Additional information received stating that the coating/surface of the fiber melted at the proximal part of the fiber, and the odor came from the melted part of the fiber.There was no issue reported with the console system that was used with the 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: 16461284
• Report Number: 2124215-2023-09577
• Device Sequence Number: 6514791
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• 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: 0000230822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 09/21/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/06/2023; 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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