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

Model Number	M0068403920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva 365 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Additional examination under magnification confirmed that the tip was unused.There was no damage along the body of the fiber.Visual examination revealed that light cannot travel to the fiber face within the sma connector to illuminate it, this indicated that the fiber was broken within the connector.The condition of the returned device would cause the device to emit insufficient energy transmission during ablation thereby confirming the event.The noted damages indicate difficulty was experienced during the procedure and was likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva 365 laser fiber was used during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure and outside the patient, the laser fiber did not work upon pedal activation and it was noted to be burned.The procedure was completed with another flexiva 365 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber was broken within the connector.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8073164
• Report Number: 3005099803-2018-02626
• Device Sequence Number: 2165605
• Product Code: GEX
• UDI-Device Identifier: 08714729808183
• UDI-Public: 08714729808183
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/21/2018

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: 09/18/2020
• Device Model Number: M0068403920
• Device Catalogue Number: 840-392
• Device Lot Number: 0000005090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 74