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	12/31/2024
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-00165 for the exalt model b scope and report number 3005099803-2025-00164 for the exalt model b monitor.It was reported to boston scientific corporation that an exalt b monitor was used on december 31, 2024.It was observed that the monitor screen goes dark after being powered on for a long period of time.Boston scientific has been unable to obtain additional information regarding a patient involvement, despite good faith efforts.
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, it was found that the device operates as intended.The logs showed that the device shutdown by itself 8 times in the last two years after the battery level dropped below 1% when the device was not plugged into the power supply.During normal operation, the device displayed switches to the screen saver (a black screen with boston scientific displayed in the middle) after two minutes of inactivity, then after the battery reached 1% level the device automatically shut down.With all the information, boston scientific concludes the reported event was not confirmed.The device was analyzed and operated as intended but failed the battery health test.The cause of the reported event was traced to the user not following the manufacturer's instructions.Therefore, the event is assigned a probable cause of failure to follow instructions.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-00165 for the exalt model b scope and report number 3005099803-2025-00164 for the exalt model b monitor.It was reported to boston scientific corporation that an exalt b monitor was used on (b)(6) 2024.It was observed that the monitor screen goes dark after being powered on for a long period of time.Boston scientific has been unable to obtain additional information regarding a patient involvement, despite good faith efforts.

• 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: 21233146
• Report Number: 3005099803-2025-00164
• Device Sequence Number: 8630445
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 0022181071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown