MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY

Model Number	M0054243R0
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of poor quality image.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt controller during an ercp procedure performed on (b)(6) 2026, for the treatment of a choledocallithiasis.During the procedure, the scope was unable to be used due to the image color quality was poor, making it difficult delineate the tissue for cannulation.The procedure was completed with a reusable scope.There were no patient complications reported as a result of this event.

• 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 ; 9145716918
• MDR Report Key: 25164357
• Report Number: 3005099803-2026-01878
• Device Sequence Number: 16093856
• Product Code: FET
• UDI-Device Identifier: 08714729990932
• UDI-Public: (01)08714729990932(11)211110(10)2131400505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/13/2026

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: M0054243R0
• Device Catalogue Number: M0054243R0
• Device Lot Number: 2131400505
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male