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

Model Number	M006R8403930
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Laser fiber was placed through the bronchoscope channel with tip remaining intact.After brief usage it was removed from the channel as planned.After re-introducing the fiber it was noted that the tip was fractured.A new laser fiber was opened and used thereafter.The tip was later found buried in the airway mucosa and was retrieved without incident.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8174341
• Report Number: 8174341
• Device Sequence Number: 11238442
• Product Code: GEX
• UDI-Device Identifier: 08714729963790
• UDI-Public: (01)08714729963790
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018
• Report Date (Section F): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006R8403930
• Device Lot Number: 0000006548
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/05/2018