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

Model Number	M00542430
Medical Device Problem Codes	Optical Problem (3001); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.
Event or Problem Description
It was reported to boston scientific that an exalt model d controller was used in the duodenum during an endoscopic retrograde cholangio pancreatography procedure on (b)(6) 2025.During the procedure, the exalt model d controller shut down.It was reported that the connection from power cord to controller is faulty.The lights on the controller flicker when the controller is connected and it remains unresponsive.Procedure was completed with an alternative device.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization correction: d4: lot number, expiration date, serial number and unique identifier (udi) #.Device evaluation summary: the returned exalt model d controller was analyzed, passed all tests performed, and exhibited normal device characteristics.The power cable the customer provided was tested with the controller and showed no signs of failure or intermittency.The reported event was not confirmed.With all the available information, boston scientific concludes that the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific that an exalt model d controller was used in the duodenum during an endoscopic retrograde cholangio pancreatography procedure on (b)(6) 2025.During the procedure, the exalt model d controller shut down.It was reported that the connection from power cord to controller is faulty.The lights on the controller flicker when the controller is connected and it remains unresponsive.Procedure was completed with an alternative device.No patient complications were reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22395132
• Report Number: 3005099803-2025-03126
• Device Sequence Number: 18439413
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 08/01/2025

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: M00542430
• Device Catalogue Number: M00542430
• Device Lot Number: 2121600120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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