MAUDE Adverse Event Report: LUMENIS LTD FIBERLASE ENDURE CO2 FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	AC-1148110
Medical Device Problem Codes	Use of Device Problem (1670); Component Missing (2306); Defective Device (2588); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the first use of the fiber, something affected the device during the cleaning and sterilization process within the facility.It was noted that the device had been left in the dryer all night at around 50 c of continuously applied heat, although the recommended drying time on manual is 20 minutes.An on-site check was performed and identified corrugated marks that appeared to be scratches on the fiber surface.It was noted that the manual for the devices was not received.Additionally, it was indicated that the aiming beam reached the tip, but the laser would not fire.The event occurred before the procedure; however, the anesthesia had already been administered.The procedure was not completed due to the same device being unavailable.There were no patient complications.This event is being reported due to procedure aborted after sedation was administered.
Event or Problem Description
It was reported that after the first use of the fiber, something affected the device during the cleaning and sterilization process within the facility.It was noted that the device had been left in the dryer all night at around 50 c of continuously applied heat, although the recommended drying time on manual is 20 minutes.An on-site check was performed and identified corrugated marks that appeared to be scratches on the fiber surface.It was noted that the manual for the devices was not received.Additionally, it was indicated that the aiming beam reached the tip, but the laser would not fire.The event occurred before the procedure; however, the anesthesia had already been administered.The procedure was not completed due to the same device being unavailable.There were no patient complications.This event is being reported due to procedure aborted after sedation was administered.
Event or Problem Description
It was reported that after the first use of the fiber, something affected the device during the cleaning and sterilization process within the facility.It was noted that the device had been left in the dryer all night at around 50 c of continuously applied heat, although the recommended drying time on manual is 20 minutes.An on-site check was performed and identified corrugated marks that appeared to be scratches on the fiber surface.It was noted that the manual for the devices was not received.Additionally, it was indicated that the aiming beam reached the tip, but the laser would not fire.The event occurred before the procedure; however, the anesthesia had already been administered.The procedure was not completed due to the same device being unavailable.There were no patient complications.This event is being reported due to procedure aborted after sedation was administered.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this fiberlase underwent a thorough analysis.Visual analysis of the fiber did not identify any physical defects as the fiber only had normal signs of use.As no damage could be identified, the reported allegations could not be confirmed.A review of the device instructions for use (ifu) was completed, and it noted the ifu contains appropriate instructions and warnings for use.The ifu indicates under "moist heat (steam) sterilization parameters" that the recommended temperature and dry time should be "132 c (270 f) and 20 minutes"; however, the customer indicted the fiber was left drying overnight at a 50 c temperature.These steps performed by the customer are out of scope for what is recommended in the ifu; therefore, a conclusion code of failure to follow instruction was assigned to this investigation.

• Brand Name: FIBERLASE ENDURE CO2 FIBER
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16788323
• Report Number: 2124215-2023-19170
• Device Sequence Number: 14847774
• Product Code: GEX
• UDI-Device Identifier: 07290109142081
• UDI-Public: 07290109142081
• 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): 11/06/2023

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-1148110
• Device Catalogue Number: AC-1148110
• Device Lot Number: 0094290622
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 10/26/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 09/22/2023; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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