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

Model Number	M0054242CE0
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the model number and lot number.Therefore, the manufacture and expiration dates are unknown.Block h11: the returned exalt model d scope was analyzed, passed all tests performed, and exhibited normal device characteristics.During visual inspection, the returned scope showed no signs of external damage.During the imaging test, the scope was connected to the controller and produced a clear image as expected.The functional check confirmed that the insertion tube tip articulated smoothly without any issues, and there was no image loss observed during operation.Electrical testing indicated that all measured values were within the acceptable range.The reported event was not confirmed.A review of the manufacturing documentation for this device was unable to be performed as the lot number unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review of the most probable lots do not identify any anomalies or deviations that could have contributed to the event review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on all gathered information, a device problem was excluded as the probable cause of the event as the device passed all tests performed, and exhibited normal characteristics.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography procedure performed on an unknown date for the treatment of a stricture.During the procedure, while the scope was in front of the papilla, the video image was lost and the system displayed the loading screen.The procedure was successfully completed with a second exalt model d scope.There were no patient complications reported as a result of this event.

• 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: 24431774
• Report Number: 3005099803-2026-00706
• Device Sequence Number: 13336605
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: (01)08714729995746
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/24/2026

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: M0054242CE0
• Device Catalogue Number: M0054242CE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• 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