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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 005099803-2025-00401 for the exalt model b scope and report number for the exalt model b monitor.It was reported to boston scientific corporation that an exalt model b monitor was used with an exalt model b scope during a bronchoscopy procedure performed on an unknow date, related to a tracheostomy.During the procedure, the home screen came back onto the monitor and the scope was not able to reconnect.The procedure was completed with another 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 b3: approximated based on the date the manufacturer became aware of the event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block b3: approximated based on the date the manufacturer became aware of the event.Block h11: with all the available information, boston scientific concludes that the investigation was unable to identify any damage or malfunction related to the exalt model b monitor.The reported event was confirmed; the exported log files show issues due to a defective exalt model b single use bronchoscope used with the exalt model b monitor.Since the investigation was unable to identify any damage or malfunction related to the exalt model b monitor, the investigation conclusion code selected for the complaint is no problem detected.The returned exalt model b monitor was analyzed, passed all tests performed, and exhibited normal device characteristics.The log file indicated a defective exalt model b single use bronchoscope.Media inspection was performed to the photo provided by the customer and the image shows the monitor displaying the home screen.The investigation was unable to identify any damage or malfunction related to the exalt model b monitor therefore, the most probable root cause for the reported complaint is no problem detected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 005099803-2025-00401 for the exalt model b scope and report number 3005099803-2025-00402 for the exalt model b monitor.It was reported to boston scientific corporation that an exalt model b monitor was used with an exalt model b scope during a bronchoscopy procedure performed on an unknown date, related to a tracheostomy.During the procedure, the home screen came back onto the monitor and the scope was not able to reconnect.The procedure was completed with another 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: 21349349
• Report Number: 3005099803-2025-00402
• Device Sequence Number: 9078477
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 0022339106
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown