MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL SINGLE USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006864640
Medical Device Problem Codes	Break (1069); Misfire (2532); Optical Problem (3001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
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 february 07, 2020 that a lighttrail single use laser fiber was used in a ureteroscopy procedure in the ureter performed on (b)(6) 2020.Reportedly, the laser settings were 0.5 joules and 5 hertz.According to the complainant, during the procedure, the aiming beam of the laser fiber was not working.The laser unit made a few crackling sounds and the nurse noticed a spark coming out from the fiber connection area.The procedure was completed with grasper.There were no patient complications reported as a result of this event.

• Brand Name: LIGHTTRAIL 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: 9750671
• Report Number: 3005099803-2020-00547
• Device Sequence Number: 11104430
• Product Code: GEX
• UDI-Device Identifier: 08714729894995
• UDI-Public: 08714729894995
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: M006864640
• Device Catalogue Number: 6464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1