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

Model Number	M0068403940
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 278.5 cm from the top of the connector to the distal tip.Visual examination revealed that the exposed glass fiber tip measured approximately 5 mm and appeared unused.Examination under magnification confirmed that the tip was unused.Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber is broken within the connector.It is likely that due to the fracture within the connector that the fiber would fail to fire.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber was broken within the connector, likely as a result of handling damage during setup.Damage within the connector of the device can result in inability for the fiber to fire.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 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 june 2, 2020 that a flexiva 1000 laser fiber used in a cystoscopy laser fragmentation and evacuation bladder procedure for a stone in the bladder performed on (b)(6) 2020.According to the complainant, during the procedure, the laser fiber was not working/not firing.The procedure was completed with a flexiva id 550 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.

• 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: 10310955
• Report Number: 3005099803-2020-02875
• Device Sequence Number: 16990394
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 02/20/2023
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000009177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR