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	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser acknowledged the fiber was good.When the device went from standby to ready, it sounded as if it was firing but no energy was being emitted.The customer had a backup omniguide co2 laser in the room, so the fiber was replaced immediately.The procedure was completed without any patient complications.The fiber was returned, and analysis identified a fracture in the fiber tip.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection did not identify any defects.Microscopic inspection of the fiber tip identified a fracture.The aiming beam exiting the tip was distorted due to the fractured fiber tip.It is probable that procedural conditions, such as physician technique, size and composition of the material being ablated contributed to the observed fiber tip fracture.The instructions for use (ifu) state the 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.Based on analysis results, a conclusion code of cause traced to component failure was assigned which indicates an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the laser acknowledged the fiber was good.When the device went from standby to ready, it sounded as if it was firing but no energy was being emitted.The customer had a backup omniguide co2 laser in the room, so the fiber was replaced immediately.The procedure was completed without any patient complications.The fiber was returned, and analysis identified a fracture in the fiber tip.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection did not identify any defects.Microscopic inspection of the fiber tip identified a fracture.The aiming beam exiting the tip was distorted due to the fractured fiber tip.It is probable that procedural conditions, such as physician technique, size and composition of the material being ablated contributed to the observed fiber tip fracture.The instructions for use (ifu) state the 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.Based on analysis results, a conclusion code of cause traced to component failure was assigned which indicates an expected or random component failure without any design or manufacturing issue.

• 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 harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16544928
• Report Number: 2124215-2023-11939
• Device Sequence Number: 17644159
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 0099610822
• 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: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Age: 75 YR
• Patient Sex: Female