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

Model Number	M006R8403940
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva id 1000 laser fiber was returned in one piece with the tip detached.The fiber measured approximately 281.1 cm from the top of the connector to the distal tip.The exposed glass portion of the distal tip measured approximately 3.5 mm and was consistent with a fracture, likely as a result of handling during the procedure.Examination under magnification revealed that the fiber tip was fractured with a portion detached.Functional analysis revealed that when the fiber was connected to the lumenis laser console, the attach fiber message disappeared indicating that the fiber was recognized by the console.The aiming beam exiting the distal tip was bright, clear and round.Effective transmission of the device was not measured due to the condition of the tip.Review and analysis of all available information indicated that the root cause 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 the manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation on march 19, 2019 that a flexiva id 1000 laser fiber was used in a ureteroscopy with laser procedure in the ureter performed on (b)(6) 2019.Reportedly, the laser unit used was a lumenis p120 console.According to the complainant, during preparation, the laser fiber was not recognized by the laser unit.The procedure was completed with a different device.There was no serious injury nor adverse patient effects as a result of this event.This event has been deemed an mdr-reportable event based on investigation results which revealed that the fiber tip detached.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8591045
• Report Number: 3005099803-2019-02446
• Device Sequence Number: 2169563
• Product Code: GEX
• UDI-Device Identifier: 08714729963813
• UDI-Public: 08714729963813
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: M006R8403940
• Device Catalogue Number: 69269
• Device Lot Number: 0000007265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1