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

Model Number	M0068403921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexiva 365 laser fiber was analyzed, and a visual evaluation noted that the fiber was returned with the body broken.The fiber measured approximately 177.8 cm from the top of the connector to the break.The remainder of the fiber including the distal tip was not returned.Examination under magnification confirmed that the pattern on the body break is consistent with a fracture.Since the condition of the coating at the body break is stretched with no discoloration or melting, it indicates that the fiber was not fired after it had been broken.No other issues with the device were noted.The analysis of returned device found that the fiber was broken.It is likely that the handling of the device during setup caused damage to the fiber.The body of the fiber was likely fractured as a result of handling, possibly as the fiber interacted with the scope.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
A flexiva 365 laser fiber was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and the laser fiber was broken.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10242366
• Report Number: 3005099803-2020-02584
• Device Sequence Number: 2485893
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 01/13/2023
• Device Model Number: M0068403921
• Device Catalogue Number: 840-392
• Device Lot Number: 0000008982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1