MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXCELON; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00564100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The needle malfunctioned and could not be advanced consistently through the sheath.This made it difficult to obtain adequate specimens for diagnosis and also put the patient at risk of injury.

• Brand Name: EXCELON
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside dr; spencer IN 47460
• MDR Report Key: 16512001
• Report Number: 16512001
• Device Sequence Number: 20424760
• Product Code: EOQ
• UDI-Device Identifier: 08714729748229
• UDI-Public: (01)08714729748229(17)250208(10)28838162
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023
• Report Date (Section F): 02/15/2023

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: M00564100
• Device Catalogue Number: M00564100
• Device Lot Number: 28838162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• 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: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 02/15/2023