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

Model Number	M00542430
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
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 controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026 for the treatment of a biliary obstruction.During the procedure the image would flicker causing loss of visualization.The procedure was completed with the original device.There were no patient complications reported as a result of 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, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25661271
• Report Number: 3005099803-2026-02613
• Device Sequence Number: 16053948
• Product Code: FET
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901(11)210804(10)2121600140
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 09/30/2026

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: M00542430
• Device Catalogue Number: M00542430
• Device Lot Number: 2121600140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/04/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown