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

Model Number	M006R8403911
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexiva id 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 306.7 cm from the end of the connector to the end of the exposed glass tip.The exposed glass measured 4 mm and appeared degraded.Examination under magnification confirmed the pattern of the tip is consistent with normal degradation.Light from the sma connector was dim and distorted, indicating a fracture within the fiber connector.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the exposed glass tip had normal degradation.Additionally, the light from the sma connector was dim and distorted, indicating a fracture within the connector.Fibers are consumable and intended to degrade with use.It is likely that procedural handling of the fiber setup or use contributed to the fiber connector fracture.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.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 instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a flexiva id 200 laser fiber was used in ureteroscopy procedure in the lower pole of kidney performed on (b)(6) 2021.The laser unit used was a lumenis 120 watt laser console withlaser settings of 0.8 joules and 8 hertz.During the procedure, the laser fiber was working for five minutes and suddenly stopped firing in the middle of the case.The energy from the laser to the fiber was still occurring, but nothing was transmitting from the tip.The procedure was completed with another flexiva id 200 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 (TM) ID 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: 12049325
• Report Number: 3005099803-2021-02979
• Device Sequence Number: 19940644
• Product Code: GEX
• UDI-Device Identifier: 08714729963769
• UDI-Public: 08714729963769
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 10/05/2023
• Device Model Number: M006R8403911
• Device Catalogue Number: 69271
• Device Lot Number: 0000010037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1