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

Model Number	M00542430
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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.
Event or Problem Description
Note: this report pertains to an exalt d controller used with two exalt model d scopes in the same procedure.It was reported to boston scientific corporation that two exalt model d scopes were used with an exalt controller during an unknown procedure performed on an unknown date.During the procedure, the scope malfunctioned and the image appears for a few seconds and then blacked out.A second exalt scope was used and the same malfunction occurred.There was no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to an exalt d controller used with two exalt model d scopes in the same procedure.It was reported to boston scientific corporation that two exalt model d scopes were used with an exalt controller during an unknown procedure performed on an unknown date.During the procedure, the scope malfunctioned and the image appears for a few seconds and then blacked out.A second exalt scope was used and the same malfunction occurred.There was no patient complications reported as a result of this event.Additional information received on january 14, 2026 confirming that the procedure date was (b)(6) 2025.
Additional Manufacturer Narrative
Block h2: additional information in b5 confirming event date of december 16, 2025.Correction to g3 manufacturer aware date.Block h6: imdrf code a06 captures the reportable event of loss of visualization.

• 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: 24021218
• Report Number: 3005099803-2026-00131
• Device Sequence Number: 10550172
• Product Code: FET
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901(11)210623(10)2117401069
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 2117401069
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown