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

Model Number	M00542421
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block h11: the reported issue of poor image quality was confirmed based on the photo provided, which showed abnormal color distortion.However, the device was not returned for investigation and could not be physically analyzed.No technical analysis was performed because the device was not returned for evaluation.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.With all available information, the most probable cause for the event could not be established due to lack of evidence.
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) 2026, for the treatment of primary sclerosing cholangitis.During the procedure, the image cut out and became distorted, troubleshooting included unplugging and reconnecting the scope, but the controller then powered down, and the image did not return.The procedure was completed with a reusable scope.There were no patient complications reported as a result of this event.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• 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: 25082288
• Report Number: 3005099803-2026-01640
• Device Sequence Number: 10395647
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)260708(10)34384770
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/15/2026

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 Expiration Date: 07/08/2026
• Device Model Number: M00542421
• Device Catalogue Number: M00542421
• Device Lot Number: 0034384770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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