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

Model Number	M006R8403910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A flexiva id laser fiber was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The device was analyzed and the investigation results revealed that the laser fiber was broken within the connector.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.This event was reported by a bsc sale rep.The reported healthcare facility is: (b)(6).(b)(4).Investigation results: the returned flexiva id laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The fiber body measured 313.3 cm from the distal tip to the proximal end of the sma connector.The exposed glass tip measured 3.9 mm and appeared to have degradation.A functional evaluation revealed that there was no light from the sma connector, indicating that there was a fracture within the connector.No other problems with the device were noted.The fracture within the fiber connector could have been likely cause by procedural handling of the fiber during setup or use.A broken fiber within the connector of the device can result in insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire.Review and analysis of all available information indicated that the most probable 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.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14435755
• Report Number: 3005099803-2022-02652
• Device Sequence Number: 5579118
• Product Code: GEX
• UDI-Device Identifier: 08714729963752
• UDI-Public: 08714729963752
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 02/22/2024
• Device Model Number: M006R8403910
• Device Catalogue Number: 69269
• Device Lot Number: 0000010642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown