MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006L8405930
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the device had decreased in laser light and vaporization.The procedure was completed with another fiber without any patient complications.Analysis of the returned device identified a fracture within the fiber connector; therefore, the reportability criteria is met based on this investigation finding.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection confirmed that the fiber was received in one piece with no defects.Microscopic inspection found the fiber tip was in good condition.There was no light exiting the connector face, which could be a result of an internal connector fracture.Functional inspection found with no aiming beam.Fracture within the connector could occur during procedural handling of the fiber during setup or use.This could result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.The instructions for use (ifu) states: carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.

• Brand Name: FLEXIVA PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21940666
• Report Number: 2124215-2025-27484
• Device Sequence Number: 9055873
• Product Code: GEX
• UDI-Device Identifier: 08714729978596
• UDI-Public: 08714729978596
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210925
• 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
• Report Date (Section B): 05/01/2025

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: M006L8405930
• Device Catalogue Number: M006L8405930
• Device Lot Number: 0033948984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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