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

Model Number	M006L8405911
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to third of three devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2022-02945 for the first flexiva pulse laser fiber, mfr report # 3005099803-2022-02946 for the second flexiva pulse laser fiber & mfr report for the third flexiva pulse laser fiber.It was reported to boston scientific corporation on (b)(6) 2022.That three flexiva pulse 242 laser fibers were used in a percutaneous nephrolithotomy (pcnl) procedure for a stone treatment in the kidney performed on (b)(6) 2022.The laser unit used was a lumenis p120 laser console.During the procedure, when the physician plugged in each of the laser fibers and started firing, the device started smoking.The fiber connector was noted to be hot to the touch.There was no reported burn injury to the user or to the patient.The procedure was completed with a flexiva pulse 365 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14549853
• Report Number: 3005099803-2022-02947
• Device Sequence Number: 17441812
• Product Code: GEX
• UDI-Device Identifier: 08714729978626
• UDI-Public: 08714729978626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/31/2022

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 Expiration Date: 01/06/2025
• Device Model Number: M006L8405911
• Device Catalogue Number: 2130-01
• Device Lot Number: 0028640672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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