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	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code a1802 is being used to capture the reportable event of device contaminated by manufacture or shipping.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2026 for treatment of cholangiocarcinoma.During preparation for the procedure, the nurse opened the exalt model d scope and unknown spots were observed on the interior packaging.The scope was successfully used to complete procedure.There was no reported 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: 24251909
• Report Number: 3005099803-2026-00440
• Device Sequence Number: 9658200
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)270218(10)35883035
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 02/03/2026

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: 0035883035
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 02/18/2025
• 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