MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403921
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on october 16, 2019 that a flexiva id 365 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the kidney performed in (b)(6) 2019.Reportedly, the laser unit used was a lumenis 100 watt console.According to the complainant, during the procedure, the laser fiber was not working properly and the junction attachment was melted by the laser generator.Reportedly, there was no burn injury to the user.The procedure was completed with another flexiva id 365 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9281329
• Report Number: 3005099803-2019-05364
• Device Sequence Number: 2588598
• Product Code: GEX
• UDI-Device Identifier: 08714729963783
• UDI-Public: 08714729963783
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 07/31/2022
• Device Model Number: M006R8403921
• Device Catalogue Number: 69271
• Device Lot Number: 0000008186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1