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

Model Number	M006R8403911
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.(b)(4) investigation results: the returned flexiva id 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 315 cm from the end of the connector to the end of the exposed glass tip.The exposed glass tip measured 4 mm and appeared in good condition.There was distorted light from the sma connector, indicating a fracture within the fiber connector.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that there was a distorted light from the sma connector, indicating a fracture within the fiber connector, which likely resulted in the reported event.It is likely that procedural handling of the fiber setup or use contributed to the fiber connector fracture, resulting in the reported event.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on june 22, 2021 that a flexiva 200 laser fiber was used in a procedure in the ureter performed on an unknown date.During the procedure, the laser fiber did not have a pilot light.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: this event has been deemed a reportable event based on the investigation finding of the laser fiber broken within the connector.

• 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: 12421535
• Report Number: 3005099803-2021-04595
• Device Sequence Number: 16971193
• Product Code: GEX
• UDI-Device Identifier: 08714729963769
• UDI-Public: 08714729963769
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: 03/02/2024
• Device Model Number: M006R8403911
• Device Catalogue Number: 69271
• Device Lot Number: 0000010696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1