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

Model Number	M0054242CE1
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an exalt model d scope was utilized during an endoscopic retrograde cholangiopancreatography procedure on (b)(6) 2025, for the treatment of stones.During the procedure, the picture and the light stop working.The nurse changed to a new scope.The procedure was completed with another exalt model d scope.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Imdrf code a06 captures the reportable event of loss of visualization.
Event or Problem Description
It was reported an exalt model d scope was utilized during an endoscopic retrograde cholangiopancreatography procedure on (b)(6) 2025, for the treatment of stones.During the procedure, the picture and the light stop working.The nurse changed to a new scope.The procedure was completed with another exalt model d scope.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Device evaluation summary: the exalt model d scope was returned for analysis.During the visual 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.However, if the umbilicus connector cable was moved the image was lost.During the electrical test, the electrical test measurements were within the normal values.Based on the evidence, the as reported code of scope - loss of visualization can be confirmed.With all the available information, boston scientific concludes that the most probable cause is cause traced to component failure.

• 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: 23237629
• Report Number: 3005099803-2025-05178
• Device Sequence Number: 9830387
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: (01)08714729995753(17)270327(10)36166938
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0036166938
• 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: 09/13/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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