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

Model Number	M00542751
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
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number.For the exalt model b scope and report number 3005099803-2025-00403 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.
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: the returned exalt model b scope was analyzed, it returned without any visual damages.During the functional test the scope was connected to the capital equipment and no image was displayed on the screen, the reuse error appeared.The electrical test measurements were within the normal values.During the media inspection, the attached photo showed the device connected, however, the screen stayed at home.The reported event was confirmed.The log files from the device indicate that the sud was used more than once and exceeded its usage limit.According to the instructions for use (ifu), the exalt monitor provides a warning when there are 30 minutes remaining of the 12 hour use time limit.When the limit is reached, the bronchoscope will no longer function, and the monitor will display an sud reuse error screen.Based on all gathered information, the probable cause selected is 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 3005099803-2025-00405 for the exalt model b scope and report number 3005099803-2025-00403 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.

• Brand Name: EXALT MODEL B SINGLE USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; suite 100; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21365427
• Report Number: 3005099803-2025-00405
• Device Sequence Number: 8451732
• Product Code: EOQ
• UDI-Device Identifier: 00191506007492
• UDI-Public: 00191506007492
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 09/01/2025
• Device Model Number: M00542751
• Device Catalogue Number: 4275
• Device Lot Number: 0032840150
• 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: 05/26/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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