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

Model Number	M006R8403930
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva id 550 laser fiber was returned in one piece.The fiber measured approximately 375.4 cm from the top of the connector to the tip.No exposed glass tip remained on the device.Examination under magnification revealed that the fiber tip was fractured with a portion detached.The remainder of the distal tip was not returned.Visual examination revealed that light cannot travel well to the fiber face within the sma connector to fully illuminate it, indicating that the fiber is broken within the connector.It is likely that due to the fracture within the connector that the fiber connector would overheat, confirming the complaint.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 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 february 4, 2020 that a flexiva id 550 laser fiber was used in a holmium laser enucleation of the prostate (holep) procedure in prostate performed on (b)(6) 2020.Reportedly, the laser unit used was a lumenis 20 watt laser console with settings of: 2 joules with 60 hertz, 2 joules with 20 hertz and 1.5 joules with 30 hertz.According to the complainant, during the procedure, the laser fiber was not firing properly and the connector was noted to be hot.Reportedly, there was no burn injury to the user.The procedure was completed with another flexiva id 550 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.There were no patient complications.

• 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: 9746528
• Report Number: 3005099803-2020-00548
• Device Sequence Number: 1973831
• Product Code: GEX
• UDI-Device Identifier: 08714729963790
• UDI-Public: 08714729963790
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/24/2020

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: 11/06/2022
• Device Model Number: M006R8403930
• Device Catalogue Number: 69269
• Device Lot Number: 0000008704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1