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

Model Number	M006R8403910
Medical Device Problem Codes	Overheating of Device (1437); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report #3005099803-2021-01884 for the first flexiva id 200 laser fiber and mfr.Report for the second flexiva id 200 laser fiber laser.It was reported to boston scientific corporation on april 1, 2021 that a flexiva id 200 laser fiber was used in a ureteroscopy procedure in the kidney performed on (b)(6) 2021.The laser unit used was a lumenis 30h laser console.During the procedure, when the physician stepped on the foot pedal, there was no energy coming out from the laser fiber.The aiming beam did not show and a burning smell was noticed.Additionally, the fiber connector felt warm.Another flexiva id 200 laser fiber was opened and the same exact issue occurred.There was no burn injury to the user or to the patient.The procedure was completed with a third flexiva id 200 laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11708094
• Report Number: 3005099803-2021-01885
• Device Sequence Number: 14207745
• Product Code: GEX
• UDI-Device Identifier: 08714729963752
• UDI-Public: 08714729963752
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 01/07/2024
• Device Model Number: M006R8403910
• Device Catalogue Number: 69269
• Device Lot Number: 0000010430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR