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

Model Number	M006L8405920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure to treat kidney stones, there were five fibers that broke and cracked within minutes of using them.For all fibers, it was noted that this was the first time they had been used.All fibers were broken at the glass tip; however, it was reported that no fiber fragments fell inside the patient.The fibers were replaced, and the procedure was completed using another fiber.There were no complications or injury to the patient or users.This report is for the third fiber.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The product record review results detailed in the prr table did not determine probable cause.A device history record review (dhr) was performed and confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A labeling review was performed on the device instructions for use (ifu).The ifu cited that, the fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Based on the information available, the conclusion code "unable to exclude device problem" has been assigned as the most probable cause.
Event or Problem Description
It was reported that during the procedure to treat kidney stones, there were five fibers that broke and cracked within minutes of using them.For all fibers, it was noted that this was the first time they had been used.All fibers were broken at the glass tip; however, it was reported that no fiber fragments fell inside the patient.The fibers were replaced, and the procedure was completed using another fiber.There were no complications or injury to the patient or users.This report is for the third fiber.

• 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: 24095340
• Report Number: 2124215-2026-03210
• Device Sequence Number: 10469254
• Product Code: GEX
• UDI-Device Identifier: 08714729978589
• UDI-Public: (01)08714729978589(17)280414(10)36300485
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: M006L8405920
• Device Catalogue Number: M006L8405920
• Device Lot Number: 0036300485
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 04/15/2025
• 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