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	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a exalt model d scope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2026.During the procedure, visualization was lost when turning the scope's articulation knob was used.The procedure was completed with a new exalt model d.There was no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf code a06 captures the reportable event of loss of visualization.

• 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: 25032236
• Report Number: 3005099803-2026-01566
• Device Sequence Number: 10186146
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: (01)08714729983514
• 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): 06/04/2026

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
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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