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

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.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06439 for the exalt model d scope.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 h11: the returned exalt controller was analyzed and passed all functional tests performed.With all the available information boston scientific concludes the reported event was not confirmed.The most probable cause is device problem excluded which indicates that the investigation findings clearly confirm that there was no problem with the device.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06439 for the exalt model d scope and 3005099803-2025-06219 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.

• 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: 23651580
• Report Number: 3005099803-2025-06219
• Device Sequence Number: 4769767
• Product Code: FDT
• 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): 02/12/2026

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: 2117401045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/21/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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