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

Model Number	M0054242CE1
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2023 to treat a neoplasm.During the procedure, the physician noticed poor, grainy image quality.The physician reported that the view was very limited while descending to the duodenum and at the papilla.The procedure was able to be completed using the original scope and there were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090208 captures the reportable event of poor-quality image.
Additional Manufacturer Narrative
Block h6: imdrf device code a090208 captures the reportable event of poor-quality image.Block h10: the returned exalt model d scope was analyzed.No visual defects were observed with the scope handle, insertion tube, or umbilicus components.The distal end was inspected; no damage or obstructions were observed with the camera, no fluid ingress was observed in the lens.Elevator functionality was tested using the thumb lever on the handle of the scope; the elevator actuated "up" with no issues, however, it could not be actuated "down" with the thumb lever.The elevator was stuck on the camera overmold.The camera over-mold was pressed out of the path of the elevator with a small screwdriver, pressing on the over-mold resolved the elevator issues.The scope was plugged into an exalt model d controller and a live, clear image displayed.Articulation of the scope was tested using the knobs on the scope handle; the scope articulated in all directions and no issues were observed with the live image during this testing.The umbilicus cable and plug were manipulated to test the image integrity; no image issues were observed.An orca air/water valve button was inserted into the air/water port on the scope handle.With a live image, the air/water valve was covered to test insufflation.During this test, fluid was deposited onto the camera lens and dried; a poor quality image was observed and condensation was seen in the lens of the camera.The condensation and poor quality image cleared within 5 seconds during continued insufflation.Insufflation was tested for 2 more cycles and no additional issues were observed.The air/water valve button was depressed and irrigation was observed; during irrigation image quality is obstructed temporarily until irrigation is stopped.3 cycles of irrigation were performed; no irrigation or image issues were observed, no lens fluid ingress was observed.The scope distal tip was submerged in a beaker of water and agitated using insufflation; no image quality or lens fluid ingress issues were observed during 3 cycles of submersion tests.The reported poor-quality image complaint was not confirmed.A product labeling review identified that the device was used per the directions for use (dfu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.With all the available information, boston scientific concludes the complaint of poor quality image was not confirmed.The findings of elevator interference with the camera overmold observed during analysis is likely due to factors such as a shift in components, procedural residue, or another issue due to handling, shipping, or procedural factors during setup or use.The probable cause of the observed elevator issue was determined to be cause traced to component failure, which indicates that the problem occurred due to a random or expected component failure, in this case the interference between the camera overmold and elevator, with no indication of a design or manufacturing cause.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat a neoplasm performed on (b)(6) 2023.During the procedure, the duodenoscope had a very poor, grainy and blurry vision.The physician wasn't able to see almost anything while he was descending to the duodenum and also the papilla vision was very poor.The procedure was completed using the original scope and there were no reported patient complications as a result of this event.

• 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: 18337940
• Report Number: 3005099803-2023-06664
• Device Sequence Number: 12865778
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: 08714729995746
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/08/2024

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: 09/10/2025
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0032400924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown