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

Model Number	M0068403940
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva 1000 laser fiber was returned in one piece.The piece measured approximately 276 cm from the top of the connector to the tip.Exposed glass portion of the tip measured approximately 2.5 mm and was fractured.The fiber tip was fractured with a portion detached.The remainder of the tip was not returned.The fiber was functionally tested on a laser console.The fiber was attached to the laser console and the "attach fiber" message extinguished, indicating that the fiber was recognized by the console.The aiming beam exiting the tip was slightly dim and distorted, likely as a result of the noted condition of the tip.Laser energy was passed through the fiber and the transmission efficiency was measured to be approximately 40%.It is likely that this poor efficiency was a result of the condition of the tip as detached.Review and analysis of all available information indicated that the cause code for this event 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 dhr (device history record) review was performed and the device met all manufacturing specifications.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 (b)(6) 2019 that a flexiva 1000 laser fiber used in a bladder stone procedure in the bladder performed on (b)(6) 2019.Reportedly, the laser unit used was a lumenis 100 watt laser console with high hertz settings according to the complainant, during the procedure, there was no energy coming out from the laser fiber.There was no serious injury nor adverse patient effects reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber tip detached.

• 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: 9142663
• Report Number: 3005099803-2019-04854
• Device Sequence Number: 3137257
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/01/2019

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: 06/11/2022
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000007889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1