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

Device Problems Device-Device Incompatibility (2919); Optical Problem (3001)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: exact date unknown, event occurred in (b)(6) 2024.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: (b)(6) italy.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 this manufacturer report for the exalt model d scope, and 3005099803-2024-00370 for the exalt model d controller it was reported that an exalt model d scope was used for a procedure at an unknown date.During the procedure, the image was lost while using the electrosurgical unit.Following the event, a bsc field services technician visited the complainant site.It was determined that the loss of visualization was caused by a customer supplied video cable.The cable was replaced and the exalt system now functions as intended.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 18769370
• MDR Text Key: 336989110
• Report Number: 3005099803-2024-00509
• 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: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 02/01/2024
• 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