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

Model Number	M006L8405910
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While using the holmium laser, the laser fiber wire "burst" and burned itself in half.The laser was being used intraoperatively in the patient when this occurred.No staff were harmed, laser fiber sequestered.New laser fiber given.Patient drape evaluated for burns or harm, none noted at the time of the event.Vendor came onsite to perform a system check and output verification.The holmium unit was found to be operating to manufacturer specifications.The vendor believes the issue was due to a faulty or damaged fiber.Manufacturer response for laser fiber used for lithotripsy, flexiva pulse.(per site reporter) report pending.

• Brand Name: FLEXIVA PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 20722998
• Report Number: 20722998
• Device Sequence Number: 20492905
• Product Code: GEX
• UDI-Device Identifier: 08714729978572
• UDI-Public: (01)08714729978572(17)261031(10)32758292
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/30/2024
• Report Date (Section F): 10/30/2024

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: M006L8405910
• Device Catalogue Number: M006L8405910
• Device Lot Number: 32758292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 64 KG
• Date Report Sent to FDA: 10/30/2024