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

Model Number	M0068403931
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva 550 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm.Additional examination under magnification revealed that the tip was unused.The investigator was unable to examine the fiber face within the sma connector because light was unable to travel to the fiber face to illuminate it; this indicated that the fiber was broken within connector.The condition of the returned device would cause insufficient energy transmission during ablation thereby confirming the event.The noted damages indicate difficulty was experienced during the procedure and are 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) confirmed that the device met all material, assembly, and product specifications.
Event or Problem Description
It was reported to boston scientific corporation on march 29, 2018 that a flexiva 550 laser fiber was used during a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was dornier 21 console.According to the complainant, during the procedure and inside the patient, it was noted that the laser fiber degrades quicker than normal use and a popping and clicking sound was heard from the laser unit.The procedure was completed with another flexiva 550 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 fine.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: 7523686
• Report Number: 3005099803-2018-01512
• Device Sequence Number: 11096141
• Product Code: GEX
• UDI-Device Identifier: 08714729808213
• UDI-Public: 08714729808213
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 04/30/2018

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: 09/29/2020
• Device Model Number: M0068403931
• Device Catalogue Number: 840-393
• Device Lot Number: 0000005141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1