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

Model Number	M00542760
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization d3: date of event approximated.
Event or Problem Description
It was reported to boston scientific that an exalt model b monitor was used during a procedure.The procedure name and date information are not available.During the procedure, the exalt model b monitor was not showing any image when connecting.The device was sent to the warehouse because it's not working.The issue was likely due to a blow from the iv pole giving way or falling off the stand.The procedure was completed with another device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block b3: date of event approximated.Device evaluation summary the exalt model b monitor was returned for analysis.Customer provided pictures showed the screen was broken and shattered in multiple places, however the exalt model b monitor is functional.The reported event of damaged defective device was confirmed.The screen damaged could have affected the device performance and its integrity, leading to the event experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue.All the information compiled on this investigation determines that the most probable cause is cause traced to component failure.
Event or Problem Description
It was reported to boston scientific that an exalt model b monitor was used during a procedure.The procedure name and date information are not available.During the procedure, the exalt model b monitor was not showing any image when connecting.The device was sent to the warehouse because it's not working.The issue was likely due to a blow from the iv pole giving way or falling off the stand.The procedure was completed with a different device.No patient complications were reported.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22793121
• Report Number: 3005099803-2025-04055
• Device Sequence Number: 8286943
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: (01)00191506007805(11)220524(10)22144030
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: M00542760
• Device Lot Number: 0022144030
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown