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

Model Number	M0054243R0
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: (b)(6) hospital.(b)(6).
Event or Problem Description
Note: this report pertains to one of three devices used in the same procedure.It was reported that an exalt model d controller was utilized with two exalt model d scopes in an unknown procedure on and unknown date.During the procedure, the exalt image appeared but disappeared after a few seconds.Troubleshooting included reconnecting the scope to exalt controller still resulting in image issue.A second exalt scope was tried however with the same results.The procedure was completed with a different model device.No patient complications were reported as a result of the event.
Event or Problem Description
Note: this report pertains to one of three devices used in the same procedure.It was reported that an exalt model d controller was utilized with two exalt model d scopes on during an unknown procedure on (b)(6) 2025.During the procedure, the exalt image appeared but disappeared after a few seconds.Troubleshooting included reconnecting the scope to exalt controller still resulting in image issue.A second exalt scope was tried however with the same results.The procedure was completed with a different model device.No patient complications were 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).H2 additional information: block b3: date of event.Block b5: description of 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: 23898407
• Report Number: 3005099803-2025-06897
• Device Sequence Number: 16045886
• Product Code: FET
• UDI-Device Identifier: 08714729990932
• UDI-Public: (01)08714729990932(11)201112(10)2031700026
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: M0054243R0
• Device Catalogue Number: M0054243R0
• Device Lot Number: 2031700026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 11/12/2020
• 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