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	Leak/Splash (1354); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.
Event or Problem Description
It was reported to boston scientific corporation that a exalt model d was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026, for the treatment of stones.During the procedure, water began leaking where scope connects to exalt controller and continued to until image was lost.The procedure was completed with a reusable device.There was no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block h11: the returned exalt model d was analysis.During the visual inspection, it was seen that the device had the water connector bent and the umbilicus connector pads were corroded.During the image test, the device displayed image as expected.During the functional inspection, it was seen that the device insertion tube tip was able to articulate without issues, the image wasn't lost when the tip was being articulated.During the leak test, the device started leaking water from the water connector and the tip of the umbilicus connector.During the destructive test, it was seen that the water connector was cracked inside the umbilicus connector.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review performed for the exalt model d scope device confirmed that the event of scope loss of visualization and scope leak was defined in the risk documentation and is documented accordingly in the prr.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 reported event of scope loss of visualization cannot be confirmed.Therefore, the most probable cause is device problem excluded.With all the available information, boston scientific concludes the reported event of scope leak was confirmed.Therefore, the most probable cause for scope leak is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a exalt model d was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026, for the treatment of stones.During the procedure, water began leaking where scope connects to exalt controller and continued to until image was lost.The procedure was completed with a reusable device.There was no patient complications reported as a result of the 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: 24387938
• Report Number: 3005099803-2026-00646
• Device Sequence Number: 10208454
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)270825(10)37290032
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/18/2026

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: 0037290032
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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