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

Model Number	M006R8403911
Medical Device Problem Codes	Break (1069); Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated to (b)(6) 2020 as the exact date was not given, but it was reported that the procedure took place in (b)(6) 2020.This event was reported to the fda via a voluntary medwatch report.The report number is (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
It was reported to boston scientific corporation on october 23, 2020 that a flexiva id 200 laser fiber was used in cystoscopy ureteroscopy with laser lithotripsy and stent placement procedure in the kidney performed on(b)(6) 2020.Reportedly, the laser unit used was lumenis laser console.According to the complainant, during the procedure, the laser fiber suddenly stopped working.The staff removed the end of the fiber and it was noted to smell like smoke and burnt metal.Additionally, the "lens at the end of the fiber had broken".There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10846991
• Report Number: 3005099803-2020-05389
• Device Sequence Number: 11565781
• Product Code: GEX
• UDI-Device Identifier: 08714729963769
• UDI-Public: 08714729963769
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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 Expiration Date: 06/10/2023
• Device Model Number: M006R8403911
• Device Catalogue Number: 69271
• Device Lot Number: 0000009518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR