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

Model Number	2130-02
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ureteroscopy, the tip of the fiber burned out during activation, and the tip separated from the fiber.The tip remained inside the patient.The disconnected tip was irrigated out of the patient with saline.There was no report of patient complications.
Additional Manufacturer Narrative
The medwatch report number is: (b)(4).
Additional Manufacturer Narrative
Updated block h10: related report number.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The product record review (ppr) 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 risk review was performed and confirmed that the event of a blown/burned out and detached/broken fiber cap/tip inside the patient was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the available information, the conclusion code known inherent risk of device has been assigned as the most probable cause, as the reported adverse events are known and documented in the labeling (including both short or long term known complications or adverse reactions).
Event or Problem Description
It was reported that during ureteroscopy, the tip of the fiber burned out during activation, and the tip separated from the fiber.The tip remained inside the patient.The disconnected tip was irrigated out of the patient with saline.There was no report of patient complications.

• 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): 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: 24474518
• Report Number: 2124215-2026-11158
• Device Sequence Number: 9615481
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: (01)08714729978725(17)280826(10)37306971
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0037306971
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 08/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female