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	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d exalt model d scope was used for a ercp (endoscopic retrograde cholangiopancreatography) procedure on (b)(6), 2026.During the procedure, the scope malfunctioned causing poor quality visualization.The visual feed repeatedly became blurry and moved in and out of focus, making it difficult to maintain a clear and consistent view.There was no patient complications reported as a result of the event.The procedure was completed with the original device.
Additional Manufacturer Narrative
Block h6: imdrf code a090208 captures the reportable event of poor-quality visualization.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d exalt model d scope was used for a ercp (endoscopic retrograde cholangiopancreatography) procedure on (b)(6) 2026.During the procedure, the scope malfunctioned causing poor quality visualization.The visual feed repeatedly became blurry and moved in and out of focus, making it difficult to maintain a clear and consistent view.There was no patient complications reported as a result of the event.The procedure was completed with the original device.
Additional Manufacturer Narrative
Block h6: imdrf code (b)(6) captures the reportable event of poor-quality visualization.Block h11: the device was not returned; therefore, a physical evaluation could not be performed.Additionally, no device media was available for analysis.Due to the lack of objective evidence, the reported issue of poor image quality could not be confirmed.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.Technical analysis of the device could not be completed because the device was not returned and no supporting data or media were provided.As a result, there was insufficient information to assess device performance or to determine whether a malfunction occurred.The absence of the device and objective evidence limited the ability to perform any functional or failure analysis.Based on the available information, there is insufficient evidence to determine the root cause of the reported poor image quality or the prolonged episode of care.It could not be established whether the issue was related to device performance or procedural factors.The most probable cause is therefore classified as "cause not established".

• 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: 24637867
• Report Number: 3005099803-2026-01013
• Device Sequence Number: 13313960
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)260601(10)34149577
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/14/2026

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: 06/01/2026
• Device Model Number: M00542421
• Device Catalogue Number: M00542421
• Device Lot Number: 0034149577
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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