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

Model Number	M0054243R0
Medical Device Problem Codes	Optical Problem (3001); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the exalt model d controller was used in an endoscopic retrograde cholangiopancreatography procedure on (b)(6) 2025.During the procedure the exalt model d controller powered off during case.The controller was restarted on to move forward with case.However, it continued to power off.The account borrowed an exalt controller unit from another room to discover the same issue.The account moved forward to swap the power cable provided by biomed and completed case with no patient complications.The account provided replacement cable to work with no issues.Procedure was completed with another exalt model d controller.No patient complications were reported as a result of the event.The original exalt controller was reinstalled and tested with no power issues.This record represents the original exalt controller.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.

• Brand Name: EXALT CONTROLLER
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 23303682
• Report Number: 3005099803-2025-05418
• Device Sequence Number: 9980326
• Product Code: FDT
• UDI-Device Identifier: 08714729990932
• UDI-Public: (01)08714729990932(11)210804(10)2121600098
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: M0054243R0
• Device Catalogue Number: M0054243R0
• Device Lot Number: 2121600098
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 08/03/2021
• 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