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

Model Number	M0054242CE0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was during an endoscopic retrograde cholangiopancreatography (ercp) procedure for treatment of stones on (b)(6) 2023.At two times during the procedure, visualization was lost and the loading screen appeared.After unplugging the scope and reconnecting it, visualization was restored.The procedure was successfully completed using the original device.There have been 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.Block h10: the returned exalt model d scope was visually inspected; no external defects were identified with the scope handle, insertion tube, distal end, or umbilicus cable.The gold pads of the umbilicus plug had signs of damage or corrosion.The elevator was tested using the thumb lever on the handle; no elevator actuation issues were observed.The scope was plugged into an exalt model d controller; a live, clear image displayed.No articulation issues were observed, the knobs and distal end articulated in all directions and combinations of directions.No issues with the live image were observed during this testing.The umbilicus was manipulated by lifting up at the connection with the controller; image was lost; the 5-dot screen was observed and then the exalt boot screen.The scope was unplugged and plugged back into the controller.A live image appeared and was disrupted again by manipulating the umbilicus plug; the 5-dot screen and then the scope error screen were observed.The reported event of loss of visualization was confirmed.The handle of the device was opened and the repeater button pcba was visually inspected; no visual defects inside the scope were observed.The gold pads of the umbilicus were wiped with 70% ipa.The scope was plugged back into the controller; the same image issues were observed.The umbilicus connector was opened and components within were visually inspected; no damage or signs of residue or corrosion was observed inside the connector.Based on all gathered information, boston scientific concludes that the reported event was confirmed.It is likely that contamination of the umbilicus pads, potentially due to contact with procedural or cleaning materials used in the endoscopy suite contributed to the reported event, as visual inspection and in-process image tests would likely identify any such damage or contamination incurred during manufacturing.Therefore, the probable cause for the reported event is adverse event related to procedure, which indicates that factors external to the exalt model d scope likely contributed to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was during an endoscopic retrograde cholangiopancreatography (ercp) procedure for treatment of stones on (b)(6) 2023.At two times during the procedure, visualization was lost and the loading screen appeared.After unplugging the scope and reconnecting it, visualization was restored.The procedure was successfully completed using the original device.There have been no patient complications reported 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: 18343858
• Report Number: 3005099803-2023-06737
• Device Sequence Number: 20216659
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: 08714729995746
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 02/13/2024

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: 10/25/2025
• Device Model Number: M0054242CE0
• Device Catalogue Number: 4242CE
• Device Lot Number: 0032725970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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