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

Model Number	M0054243R0
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-01378 for the first exalt model d scope, number 3005099803-2025-01377 for the second exalt model d scope for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d controller was used with two exalt model d scopes, during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after 10-15 minutes the image was lost multiple times.The exalt controller rebooted and the image would recover but it appeared to have a pink tint.The physician switched to a second exalt model d scope and experienced the same reported issue.The procedure was completed with a reusable scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: the returned exalt model d controller was analyzed, it was observed that the top cover had finish damage and the front panel had scratches and cosmetic issues.The connector socket was discolored and there is unknown contamination inside the connector socket and on the catheter interface contacts.The contamination is likely due to repeat use and wear and tear on the catheter connection, or improper cleaning of the unit during maintenance.With all the available information, boston scientific concludes the reported event was confirmed.The conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-01378 for the first exalt model d scope, number 3005099803-2025-01377 for the second exalt model d scope and report number for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d controller was used with two exalt model d scopes, during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after 10-15 minutes the image was lost multiple times.The exalt controller rebooted and the image would recover but with a pink image.Another scope was utilized and experienced the same reported issue.The procedure was completed with a reusable scope.There were no patient complications reported as a result of this 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21739296
• Report Number: 3005099803-2025-01375
• Device Sequence Number: 4022260
• Product Code: FDT
• UDI-Device Identifier: 08714729990932
• UDI-Public: (01)08714729990932(11)210813(10)2122500245
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: M0054243R0
• Device Catalogue Number: 4243
• Device Lot Number: 2122500245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown