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

Model Number	M0054242CE1
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3 approximated based on the date the manufacturer became aware of the event.Block h6 problem code a090208 captures the reportable event of poor quality image inside the patient.
Event or Problem Description
It was reported that an exalt model d single use scope was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure at an unknown date.During the procedure, the image quality deteriorated.The procedure was completed with a second exalt scope.There were no patient complications.
Event or Problem Description
It was reported that an exalt model d single use scope was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure at an unknown date.During the procedure, the image quality deteriorated.The procedure was completed with a second exalt scope.There were no patient complications.
Additional Manufacturer Narrative
Block b3 approximated based on the date the manufacturer became aware of the event.Block h6: problem code a090208 captures the reportable event of poor-quality image inside the patient.Block h10: the scope returned didn't have any visual damage, the device also returned with a locking device.During functional testing, the scope was connected to an exalt controller.The scope displayed an image however, the image wasn't as clear as it should be.It was discovered that the device was filled with procedural residue.The device camera was cleaned and flushed which resulted in a clearer image.Electrically, no shorts in the circuit were detected.Poor quality image was able to be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) and product label.This investigation is assigned a most probable conclusion code of adverse event related to procedure.This conclusion was selected because during the product analysis of the device, the returned scope didn't have any visual damage.When it was connected to the exalt controller, the scope displayed an image however, it was poor.It is likely that the scope filled up with procedural residue while it was advancing through the patient which affected the leds on outside of the camera.There was no residue behind the lens in the camera.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18944479
• Report Number: 3005099803-2024-01190
• Device Sequence Number: 8204185
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: 08714729995746
• 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): 05/21/2024

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 Expiration Date: 01/17/2026
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0033238767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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