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

Model Number	M006L8406930
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The product record review (prr) results detailed in the prr table did not determine probable cause of the complaint.A risk review was completed and confirmed that the event of "failure to operate" 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 to carefully inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device and return it to the manufacturer for a replacement.Based on the information available, the conclusion code "cause not established" has been assigned as the most probable cause for the complaint.
Event or Problem Description
It was reported that during procedure, three separate fibers were tried however no energy would pass down the fiber.A connection issue was also indicated.The patient, who was under general anesthesia, was woken up and will need further surgery.The procedure was not completed due to this event.It was noted that there was no issue with the laser.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation unknown.Device 1 of 3.

• 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: 24899590
• Report Number: 2124215-2026-20734
• Device Sequence Number: 18617059
• Product Code: GEX
• UDI-Device Identifier: 08714729978695
• UDI-Public: (01)08714729978695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: M006L8406930
• Device Catalogue Number: M006L8406930
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/16/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown