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

Model Number	M006L8406940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser wire came apart from the fiber connector.The procedure was completed with another 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.However, the connector was not received, it was not attached to the fiber body.Visual analysis of the returned fiber identified that the fiber connector was detached from the fiber body and not returned.The fiber had no signs of usage.It is likely that procedural handling and procedural conditions of the device during set-up, use contributed to the fiber body break.The fiber had no signs of usage.The ifu states, carefully inspect the fiber for kinks, punctures, fractures, a broken tip, jacket or fiber or other particulates or pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused device, return it to boston scientific for replacement.Therefore, the investigation conclusion code assigned is cause traced to component failure which indicates expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the laser wire came apart from the fiber connector.The procedure was completed with another device and no patient complications was reported.

• Brand Name: FLEXIVA PULSE ID
• 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: 19811234
• Report Number: 2124215-2024-45215
• Device Sequence Number: 8380069
• Product Code: GEX
• UDI-Device Identifier: 08714729978701
• UDI-Public: 08714729978701
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/12/2024

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 Expiration Date: 03/19/2026
• Device Model Number: M006L8406940
• Device Catalogue Number: 2130-02
• Device Lot Number: 0031260818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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