MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT Controller; Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Model Number	M0054243R0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf code a06 captures the reportable event of loss of visualization.
Event or Problem Description
Note: this report pertains to one of two devices used in the same procedure.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt controller during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on an unknown date.During the procedure, the scope malfunctioned and the image went blank.The procedure was completed with a reusable scope.There was no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two devices used in the same procedure.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt controller during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on an unknown date.During the procedure, the scope malfunctioned and the image went blank.The procedure was completed with a reusable scope.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event approximated based on the date the manufacturer became aware of the event.Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block h11: investigation summary.The exalt model d controller was returned for analysis.A product analysis identified moderate wear and tear to exterior however the controller passed the initial testing.Therefore, the reported allegation of loss of visualization in this complaint was not confirmed.A similar complaint review was completed.There were no emerging trends identified that warrant further action.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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 ; +1(914)571-6918
• MDR Report Key: 23881947
• Report Number: 3005099803-2025-06850
• Device Sequence Number: 9605771
• Product Code: FET
• UDI-Device Identifier: 08714729990932
• UDI-Public: (01)08714729990932(11)220617(10)2216800774
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/18/2026

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: 2216800774
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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