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

Model Number	M00542430
Medical Device Problem Codes	Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization block e1: (b)(6).
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06490 for the exalt model d scope and.For the exalt d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt d controller during an unknown procedure on (b)(6) 2025.During the procedure, the controller stopped working and visualization was lost.The controller was restarted twice but would not power up, troubleshooting confirm power supply cables were properly connected.There was no patient complications reported as a result of the event.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06490 for the exalt model d scope and 3005099803-2025-06489 for the exalt d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt d controller during an unknown procedure on (b)(6) 2025.During the procedure, the controller stopped working and visualization was lost.The controller was restarted twice but would not power up, troubleshooting confirm power supply cables were properly connected.There was no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block e1: (b)(6).Block h11: the returned exalt model d controller was returned for analysis.During the visual inspection, it was observed that the controller was in poor cosmetic condition.There was visible corrosion damage to the top cover and main housing of controller.The optical sensors and catheter interface were damaged by fluid ingress.The reported allegation was confirmed.A labeling review was performed.The instructions for use (ifu) includes specific warnings/instructions such as: use a 15 to 70 percent isopropyl alcohol in purified water solution and a cloth to clean the controller enclosure, front panel, and power cable do not allow fluids to enter the enclosure, power cable connections, catheter cable receptacle, or component/accessory connections.There is no indication that the device was not used in accordance with the ifu.Based on all gathered information, it is likely that the fluid ingress is due to improper cleaning of the unit during maintenance.Therefore, the conclusion code selected for this complaint is: cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.

• 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: 23647651
• Report Number: 3005099803-2025-06489
• Device Sequence Number: 13268650
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901(11)200729(10)2021100013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 2021100013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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