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

Model Number	M00542420
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2025.During the procedure, the scope malfunctioned after approximately 30 minutes of normal operation, displayed an error icon with a white scope and exclamation mark, resulting in loss of video output.The procedure was completed with another exalt model d.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2025.During the procedure, the scope malfunctioned after approximately 30 minutes of normal operation, displayed an error icon with a white scope and exclamation mark, resulting in loss of video output.The procedure was completed with another exalt model d.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block h11: the returned exalt model d scope was analyzed, passed all tests performed, and exhibited normal device characteristics.During visual inspection, the returned scope showed no signs of external damage.During the imaging test, the scope was connected to the controller and produced a clear image as expected.The functional check confirmed that the insertion tube tip articulated smoothly without any issues, and there was no image loss observed during operation.Electrical testing indicated that all measured values were within the acceptable range.The reported event was not confirmed.Based on all gathered information, a device problem was excluded as the probable cause of the event as the device passed all tests performed, and exhibited normal characteristics.

• 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: 24058183
• Report Number: 3005099803-2026-00188
• Device Sequence Number: 18647649
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: (01)08714729983514(17)270514(10)36517508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: M00542420
• Device Catalogue Number: M00542420
• Device Lot Number: 0036517508
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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