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

Model Number	M006R8403921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva id 365 laser fiber was returned broken in two pieces.The first piece measured approximately 65.6 cm from the top of the connector to the break.The second piece measured approximately 212.5 cm from the break and includes the entire distal tip.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Examination under magnification confirms that the tip was unused.The conditioned of the returned device confirms the reported event.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.A review of the device history record (dhr) was performed and the device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation july 2, 2019 that a flexiva id 365 laser fiber was used in a procedure performed on (b)(6) 2019.Reportedly, the laser unit used was a holmium laser console.According to the complainant, during the procedure, the aiming beam was noted to be glowing through the shaft of the laser fiber.There were no patient complications.The patient's condition was reported to be fine.There was no serious injury nor adverse patient effects as result of this event.This event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber was broken.

• 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: 8932016
• Report Number: 3005099803-2019-04267
• Device Sequence Number: 1949081
• Product Code: GEX
• UDI-Device Identifier: 08714729963783
• UDI-Public: 08714729963783
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/26/2019

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: 08/30/2021
• Device Model Number: M006R8403921
• Device Catalogue Number: 69271
• Device Lot Number: 0000006549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1