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

Model Number M00542420

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that an exalt model d single use scope was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones on (b)(6) 2024.During procedure, the scope lost visualization and the error screen displayed.The scope was unplugged and re-plugged but visualization was not regained.Another exalt scope was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block e1: (b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Manufacturer Narrative

Block e1: (b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10 upon receipt of this scope at our quality assurance laboratory, this device was thoroughly analyzed.An image test was conducted by connecting the umbilicus to a monitor, the monitor showed the image as expected, the image is not lost after the flush test, there were no leaks detected.There were no abnormalities found during the electrical tests.The reported allegation was unable to be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.

Event Description

It was reported that an exalt model d single use scope was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones on (b)(6) 2024.During procedure, the scope lost visualization and the error screen displayed.The scope was unplugged and re-plugged but visualization was not regained.Another exalt scope was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: 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: 18660581
• MDR Text Key: 334783062
• Report Number: 3005099803-2024-00371
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: 08714729983514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0032772723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1