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

Device Problem Optical Problem (3001)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, 02/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 02/08/2024.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-00770 for the exalt controller, and 3005099803-2024-00890 for the exalt model d scope it was reported to boston scientific corporation that an exalt model d controller was used during an unspecified procedure on an unknown date.Thought the procedure, intermittent loss of the image was experienced.It was reported that this issue manifested across multiple exalt model d scopes, necessitating the facility to use tape and hold the scopes to secure the controller's connection with the exalt model d scopes as a workaround to prevent further image loss.At the time of this report, the information suggests that this issue has been observed across various cases.However, despite good faith efforts (gfe), precise details regarding the number and specifics of the affected procedures remain unknown.No patient complications were 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: 18838452
• MDR Text Key: 337680437
• Report Number: 3005099803-2024-00890
• Device Sequence Number: 1
• Product Code: FDT
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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