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

Model Number	M0068403930
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: one flexiva 550 laser fiber was returned in one piece with tip detached.The fiber measured approximately 277.8 cm from the top of the connector to the distal tip.Visual examination revealed that 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.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 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 on (b)(6) 2019 that a flexiva 550 laser fiber was used in a flexible ureteroscope stone breaking procedure in the kidney on (b)(6) 2019.According the complainant, during procedure, it was noted that there was not enough power for laser activation with various settings that were applied to the patient.The procedure was completed with a flexiva 365 laser fiber.There were 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: 8527480
• Report Number: 3005099803-2019-02015
• Device Sequence Number: 19303769
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 04/16/2021
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: 5895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1