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

Model Number M0054242CE1

Device Problem Optical Problem (3001)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event 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 stones in the bile duct performed on (b)(6) 2023.During the procedure, visualization was lost when the loading screen appeared, followed by the scope error screen.The procedure was able to be finished using the original device however, it had to be restarted multiple times.There have been no patient complications reported as a result of this event.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06888 for the exalt model d scope and 3005099803-2023-06903 for the exalt model d controller.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: block b5 (describe event or problem) associated manufacturer report numbers corrected.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06888 for the exalt model d scope and 3005099803-2023-07082 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat stones in the bile duct performed on (b)(6) 2023.During the procedure, visualization was lost when the loading screen appeared, followed by the scope error screen.The procedure was able to be finished using the original device however, it had to be restarted multiple times.There have been no patient complications reported 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: 18395152
• MDR Text Key: 331343488
• Report Number: 3005099803-2023-06888
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0030893081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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