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

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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.D4: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06440 for the exalt model d scope and for the exalt d controller.It was reported that an exalt model d scope was used with an exalt d controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, the exalt controller shutdown and visualization was lost.The procedure was completed with a reusable scope.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 3005099803-2025-06440 for the exalt model d scope and 3005099803-2025-06220 for the exalt d controller.It was reported that an exalt model d scope was used with an exalt d controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, the exalt controller shutdown and visualization was lost.The procedure was completed with a reusable scope.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 h2: model number d4 and lot number d4 updated based on additional information received on december 2, 2025.

• 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: 23655714
• Report Number: 3005099803-2025-06220
• Device Sequence Number: 21345903
• Product Code: FET
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901(11)210623(10)2117401045
• 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): 12/03/2025

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: 2117401045
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown