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

Model Number	2130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the fiber snapped approximately two inches from the tip inside the scope.The procedure was completed using another of the same device.There were no patient complications.
Event or Problem Description
It was reported that during the procedure, the fiber snapped approximately two inches from the tip inside the scope.The procedure was completed using another of the same device.There were no patient complications.
Additional Manufacturer Narrative
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.Without product return and proper evaluation of the device, the most probable cause that contributed to the event remains unknown.A review of device history 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 completed and confirmed that the event of break 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 labeling review was performed on the device instructions for use (ifu).The ifu cited: fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Based on the information provided, unable to exclude device problem is selected as the most probable cause for the complaint, as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.

• 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: 24247316
• Report Number: 2124215-2026-06025
• Device Sequence Number: 9970236
• Product Code: GEX
• UDI-Device Identifier: 08714729978763
• UDI-Public: (01)08714729978763(17)280727(10)37064832
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0037064832
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 07/28/2025
• 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