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	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to use in patient, the circulating nurse noted that laser fiber wire was not working properly.The laser fiber wire was removed from the sterile field and sequestered until given to management for follow up.The circulating nurse gave a new laser fiber wire to the surgeon and the case continued.

• 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: 8726953
• Report Number: 8726953
• Device Sequence Number: 1925256
• Product Code: GEX
• UDI-Device Identifier: 08714729963790
• UDI-Public: (01)08714729963790(17)220321(10)0000007470
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/12/2019
• Report Date (Section F): 06/12/2019

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 Model Number: M006R8403930
• Device Lot Number: 0000007470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2019
• 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: 06/12/2019