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

Device Problem Optical Problem (3001)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01173 for the exalt model d controller.It was reported that and exalt model d single use scope was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2024.During procedure, the image was lost and was unable to be recovered after multiple attempts of powering on.The account switched to a reusable scope to complete the procedure.There were no patient complications related to this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the model or 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.

• Brand Name: EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL
• 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: 18941222
• MDR Text Key: 338135625
• Report Number: 3005099803-2024-01035
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• 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