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

Model Number	AC-1059590
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after 761 joules of use the vaporization diminished.A second fiber was then tried and failed to fire.The procedure was completed with another laser system with no patient complications.Analysis of the returned fiber identified a fiber break.This complaint refers to the first fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis with the microscope confirmed the reported allegation, as the fiber tip was found to be broken.The aim beam was bright and distorted due to the fiber tip break.Analysis of the connector did not identify any anomaly.Based on analysis results, it is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip to breaking off causing the beam intensity to diminish.According to the device instructions for use, the fiberlase co2 fiber is intended for use in non-contact mode.If the tip is damaged during surgery, it can be quickly repaired using the fiberlase fiber renewal kit.

• Brand Name: FIBERLASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 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: 20455691
• Report Number: 2124215-2024-63971
• Device Sequence Number: 7203818
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• 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
• Report Date (Section B): 10/15/2024

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: 0011640623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: 77 YR
• Patient Sex: Unknown