MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT? MODEL D; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M0054242CE0
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2025.During the procedure the visualization was lost, the screen went back to the home screen.The procedure was completed with another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6.Device code a06 is being used to capture the reportable event of scope loss of visualization.
Additional Manufacturer Narrative
Block h6: device code a06 is being used to capture the reportable event of scope loss of visualization.Block h11: the returned exalt model b scope was analyzed, passed all tests performed, and exhibited normal device characteristics.A visual inspection was performed; the device did not have any visual damage.During testing, the image displayed as expected.During the functional test, the tip was articulated without any issues, the electrical test measurements were within the normal values.The reported event was not confirmed.Based on all available information, the evaluation conclusion is that no problem was detected.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2025.During the procedure the visualization was lost, the screen went back to the home screen.The procedure was completed with another device of the same model.There were no patient complications reported as a result of this event.

• Brand Name: EXALT? MODEL D
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 21977897
• Report Number: 3005099803-2025-02079
• Device Sequence Number: 15766088
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: (01)08714729995746(17)260601(10)34149571
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K193202
• 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): 10/14/2025

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: 06/01/2026
• Device Model Number: M0054242CE0
• Device Catalogue Number: M0054242CE0
• Device Lot Number: 0034149571
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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