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

Model Number	M00542421
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
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 ercp (endoscopic retrograde cholangiopancreatography) procedure performed on an unknown date, for a removal of a stent.During the procedure the image began to display a honeycomb pattern.The procedure was completed with a new exalt model d scope.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 poor quality image.Block h11: the returned exalt d scope was visually inspection, the scope returned didn't have any visual damage.During the image test, the scope was connected to the controller and displayed image as expected.During the functional test, the insertion tube tip was articulated without any issues, the image remained during the test.During the electrical test, the electrical test measurements were within the normal values.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.A risk review performed for the exalt model d scope device confirmed that the event of scope poor quality image was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the exalt model d scope device is acceptable.The device was inspected to see if there was any damage or condition that could have caused the device to have the no visualization issue as reported, specifically the honeycomb effect.However, there weren't any damages seen on the device and when the device was inspected the camera displayed image as expected and passed all testing to confirm its functionality.Based on the available information, the reported event of scope poor quality image was not confirmed.Since there weren't any damages that led to a possible cause for the reported condition the most probable cause for the reported condition is device problem excluded.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of poor-quality image.
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 an unknown date, for a removal of a stent.During the procedure the image began to display a honeycomb pattern.The procedure was completed with a new exalt model d scope.There was 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: 24582508
• Report Number: 3005099803-2026-00927
• Device Sequence Number: 18450050
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)270902(10)37351867
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/08/2026

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: M00542421
• Device Catalogue Number: M00542421
• Device Lot Number: 0037351867
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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