MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT Controller; Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Model Number	M0054243Z0
Medical Device Problem Codes	Fitting Problem (2183); Optical Problem (3001); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used in the same procedure.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt model d controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6)2026, for the treatment of bile duct stones.During the procedure, after 10 minutes inside the patient, the screen flickered then returned to normal; and after about another 5 minutes the screen became fuzzy.Troubleshooting was performed, including powering off and restarting the controller; however, the issue persisted.Unhooking the scope's umbilicus from the controller was reported to be difficult, and after plugging it back in the controller unexpectedly shutdown while rebooting.The controller was turned back on and while it was rebooting, it shut down again.Due to this, the procedure was completed with a different model device.It was reported to be difficult to remove the scope umbilicus from the controller.Per the user, the tab to release the scope did not appear to be functioning properly.No patient complications or adverse effects were reported in relation to this event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.

• Brand Name: EXALT Controller
• Common Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, 01752 ; EI 01752
• MDR Report Key: 50534785
• Report Number: 3005099803-2026-03477
• Device Sequence Number: 14943348
• Product Code: FET
• UDI-Device Identifier: 08714729990956
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: M0054243Z0
• Device Catalogue Number: M0054243Z0
• Device Lot Number: 2532802873
• 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: 08/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown