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

Model Number	M006R8403940
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific flexiva id high power single-use laser fiber didn't last the whole case, and staff needed to open a new device.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10828637
• Report Number: 10828637
• Device Sequence Number: 19836277
• Product Code: GEX
• UDI-Device Identifier: 08714729963813
• UDI-Public: (01)08714729963813
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/03/2020
• Report Date (Section F): 11/03/2020

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: M006R8403940
• Device Catalogue Number: M006R8403940
• Device Lot Number: 000009859
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 122
• Date Report Sent to FDA: 11/03/2020