MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT B MONITOR; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00542760
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b monitor was used during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the exalt model b monitor powered down.The procedure was completed with another exalt model b monitor and the same exalt model b scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: the returned exalt model b monitor was analyzed, the monitor was functioning as intended therefore the complaint cannot be confirmed.Based on all gathered information, the probable cause selected is no problem detected, which indicates that the device complaint or problem cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b monitor was used during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the exalt model b monitor powered down.The procedure was completed with another exalt model b monitor and the same exalt model b scope.There were no patient complications reported as a result of this event.

• Brand Name: EXALT B MONITOR
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TRICE MEDICAL INC; 40 general warren blvd; suite 100; malvern PA 19355
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20796227
• Report Number: 3005099803-2024-06059
• Device Sequence Number: 20566163
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: (01)00191506007805(11)240328(10)24088006(21)24088006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: M00542760
• Device Catalogue Number: 2295-05
• Device Lot Number: 0024088006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown