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

Model Number	M006L8406940
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber was not recognized by the laser.The procedure was not completed due to this event.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that the fiber was not recognized by the laser.The procedure was not completed due to this event.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The device was received in one piece and there were no defects along the length of the fiber body.The complaint was not confirmed.The investigation did not identify any abnormality in manufacturing or design from the risk review and dhr review.The impact code of cancelled/rescheduled - post sedation/sedation unknown and surgical procedure delayed are defined in the risk review and are known inherent risks of the device.

• 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; model farm road; cork CA T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19506021
• Report Number: 2124215-2024-35321
• Device Sequence Number: 7498292
• Product Code: GEX
• UDI-Device Identifier: 08714729978701
• UDI-Public: 08714729978701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 08/24/2026
• Device Model Number: M006L8406940
• Device Catalogue Number: 2130-02
• Device Lot Number: 0032292617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown