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

Model Number	2130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event was estimated as an event date was not provided by the customer.
Event or Problem Description
It was reported that during a procedure, the fiber tip broke.A new fiber was used to complete the procedure with no patient complications.
Additional Manufacturer Narrative
B3 date of event was estimated as an event date was not provided by the customer.
Event or Problem Description
It was reported that during a procedure, the fiber tip broke.A new fiber was used to complete the procedure with no patient complications.This report is for the first fiber.

• 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: 19373015
• Report Number: 2124215-2024-31153
• Device Sequence Number: 20714890
• Product Code: GEX
• UDI-Device Identifier: 08714729978756
• UDI-Public: 08714729978756
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 12/07/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030672680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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