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

Model Number	M006L8406910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related report: 2124215-2025-75699.
Event or Problem Description
It was reported that the fiber broke during the ureteroscopy procedure.Another fiber was opened, but it also broke.The procedure was completed with another device.There were no patient complications.This report is for the second broken fiber.
Additional Manufacturer Narrative
Related report: 2124215-2025-75699.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the fiber broke during the ureteroscopy procedure.Another fiber was opened, but it also broke.The procedure was completed with another device.There were no patient complications.This complaint refers to the second fiber.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23416470
• Report Number: 2124215-2025-75706
• Device Sequence Number: 8945508
• Product Code: GEX
• UDI-Device Identifier: 08714729978671
• UDI-Public: (01)08714729978671
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: M006L8406910
• Device Catalogue Number: M006L8406910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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