MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT Model D Single-Use Duodenoscope; Duodenoscope And Accessories, Flexible/Rigid

Model Number	M00542421
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an exalt model d single-use duodenoscope was utilized during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2026 for the treatment of gall stones.During the procedure, the physician passed the exalt scope into the duodenum and upon attempting to canulate, visualization was lost and blue screen appeared.The scope was replaced with another exalt and the procedure was completed.No patient complications were 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: device evaluation.Based on the available information, the root cause of the reported loss of visualization cannot be established, as the device was disposed and was not returned for analysis.The exalt model d scope was discarded; therefore, a product analysis could not be performed.The reported event of scope loss of visualization could not be confirmed due to a lack of evidence.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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the available information (and in the absence of device return), the root cause of the reported clinical observations cannot be established.

• Brand Name: EXALT Model D Single-Use Duodenoscope
• 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 ; +1(914)571-6918
• MDR Report Key: 50116401
• Report Number: 3005099803-2026-03146
• Device Sequence Number: 5252748
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)280109(10)38306642
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: M00542421
• Device Catalogue Number: M00542421
• Device Lot Number: 0038306642
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 01/09/2026
• 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