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

Model Number	M0054242CE0
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact event date was not reported.The event date of september 1, 2025, was chosen as best estimate based on the bsc aware date.Block h6: imdrf device code a06 captures the reportable event of scope loss of visualization.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used to treat strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, visualization was lost while the scope was positioned in front of the papilla.The monitor displayed a loading screen that did not recover.Troubleshooting steps were promptly initiated, including disconnecting and reconnecting the scope, securing the rear connection, and restarting the controller.The scope's umbilicus was confirmed to be securely connected to the umbilicus receptacle of the controller, with no damage noted to either the receptacle or the cables.The procedure was completed using another exalt model d scope, connected to the same controller.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used to treat strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, visualization was lost while the scope was positioned in front of the papilla.The monitor displayed a loading screen that did not recover.Troubleshooting steps were promptly initiated, including disconnecting and reconnecting the scope, securing the rear connection, and restarting the controller.The scope's umbilicus was confirmed to be securely connected to the umbilicus receptacle of the controller, with no damage noted to either the receptacle or the cables.The procedure was completed using another exalt model d scope, connected to the same controller.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact event date was not reported.The event date of september 1, 2025, was chosen as best estimate based on the bsc aware date.Block h6: imdrf device code a06 captures the reportable event of scope loss of visualization.Device evaluation summary: the exalt model d scope was returned for analysis.The scope passed all tests performed and exhibited normal device characteristics.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.The reported event was not confirmed.With all the available information, boston scientific concludes that the most probable cause is no problem detected.

• Brand Name: EXALT? MODEL D
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23076863
• Report Number: 3005099803-2025-04597
• Device Sequence Number: 20020836
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: (01)08714729995746(17)270115(10)35639770
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: M0054242CE0
• Device Catalogue Number: M0054242CE0
• Device Lot Number: 0035639770
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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