MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403921
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated to (b)(6), 2020 based on the date the manufacturer became aware of the event.(b)(4).Investigation results: the returned flexiva 365 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.Visual examination revealed that the exposed glass fiber tip measured approximately 4 mm and appeared unused.The examination under magnification confirmed that the tip was unused.The fiber measured 280 cm.Visual inspection of the connector found that there was low light output from the sma connector, indicating that fiber was likely broken within the connector.A functional test of the fiber was done and connected to the console.The fiber was connected and a round clear aiming beam was visible.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber was found that there was low light within the sma connector, indicating that the fiber was likely broken within the connector.Damage within the connector of the device can result in inability for the fiber to fire.If firing the laser with a device damaged within connector was attempted, it would likely overheat.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
It was reported to boston scientific corporation on january 30, 2020 that a flexiva 365 laser fiber was used in a lithotripsy procedure performed on an unknown date.According to the complainant, during the procedure, the laser fiber was not recognized by the laser unit.The procedure was completed with the another flexiva 365 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 broken within the connector.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10209630
• Report Number: 3005099803-2020-02483
• Device Sequence Number: 19356618
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: 07/17/2022
• Device Model Number: M0068403921
• Device Catalogue Number: 840-392
• Device Lot Number: 0000008100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1