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

Model Number	M006L8405921
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before the procedure, the fiber tip was broken.The procedure was completed with another fiber device and no patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The device was received in one piece.Visual analysis of the returned fiber identified that the fiber tip was broken off.The light exiting the connector face was bright and round.The complaint was confirmed.A fiber break can occur during procedural handling of the fiber when opening the package may have led to the fiber tip breakage.The ifu states, care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.The investigation did not identify any abnormality in manufacturing or design from the risk review and dhr review.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure.
Event or Problem Description
It was reported that before the procedure, the fiber tip was broken.The procedure was completed with another fiber device and no patient complications were reported.

• Brand Name: FLEXIVA PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19273759
• Report Number: 2124215-2024-28149
• Device Sequence Number: 15195488
• Product Code: GEX
• UDI-Device Identifier: 08714729978633
• UDI-Public: 08714729978633
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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 Model Number: M006L8405921
• Device Catalogue Number: 2130-01
• Device Lot Number: 0033145307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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