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

Model Number	M0068403940
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.Investigation results: the returned flexiva 1000 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured approximately 280.7 cm from the top of the connector to the tip.No exposed glass tip remained on the device.Examination under magnification revealed that the fiber tip was fractured with a portion detached.The remainder of the distal tip was not returned.No other issues with the device were noted.The reported event was not confirmed.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 event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on february 13, 2020 that a flexiva 1000 laser fiber was used in a cysto laser litho procedure in the ureter performed on an unknown date.According to the complainant, during the procedure, there was no energy coming out from the laser fiber and the laser fiber was not firing.The procedure was completed with another flexiva 1000 laser fiber.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of the laser fiber tip detached.

• 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: 9938809
• Report Number: 3005099803-2020-01566
• Device Sequence Number: 13613981
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 02/08/2022
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000007284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1