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

Model Number M00542421

Device Problem Optical Problem (3001)

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

Event Date 01/08/2024

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) performed on (b)(6) 2024.About 20 minutes into the procedure, the scope stopped displaying an image.The procedure was successfully completed using another exalt scope.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: with all the available information boston scientific concludes that the reported event was able to be confirmed, as loss of visualization was replicated during analysis.The returned device was visually inspected; no external defects were identified.The scope was plugged into an exalt model d controller; a live, clear image was displayed.A flush test was performed, and the image remained consistent.However, after connecting the scope a second time, there was no visualization.The reported complaint was confirmed.During the electrical testing, no shorts in the circuit were detected.After disassembling the handle, evidence of residue was found between pins 4 and 5 in the repeater pcb (printed circuit board).After the residue was removed, the scope was re-connected to the controller and a live image was displayed.This investigation is assigned a most probable conclusion code of cause trace to component failure which indicates that the problems were traced to a random component failure with no evidence of a design or manufacturing issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.About 20 minutes into the procedure, the scope stopped displaying an image.The procedure was successfully completed using another exalt scope.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: 18621839
• MDR Text Key: 334314126
• Report Number: 3005099803-2024-00267
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0032920760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2023
• 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