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

Model Number	M006R8403931
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 550 laser fiber was used during a bladder stone procedure performed on (b)(6) 2018.Reportedly, the laser unit used was lumenis p100 laser console with settings of 1.5 joules and 20 hertz.According to the complainant, about 15 minutes into the procedure, the operator attempted to advance the fiber in the working channel of the scope when the protective coating of the laser fiber sheared a little bit and the fiber body broke inside the working channel of the cystoscope.The laser fiber was taken out from the scope and scrape marks were noted inside the working channel of the cystoscope.The procedure was completed with another flexiva id 550 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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7558091
• Report Number: 3005099803-2018-01686
• Device Sequence Number: 1432802
• Product Code: GEX
• UDI-Device Identifier: 08714729963806
• UDI-Public: 08714729963806
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: 10/23/2020
• Device Model Number: M006R8403931
• Device Lot Number: 0000005234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1