MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542430

Device Problem Optical Problem (3001)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: device 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 3005099803-2023-05813 for the exalt model d single-use scope.It was reported that an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography (ercp) on an (b)(6) 2023.During the procedure, the exalt controller displayed the ercp error message.Therefore, the image was lost.The procedure was able to be completed with another exalt model d scope.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-05813 for the exalt model d single-use scope.It was reported that an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography (ercp) on an (b)(6) 2023.During the procedure, the exalt controller displayed the ercp error message.Therefore, the image was lost.The procedure was able to be completed with another exalt model d scope.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d controller was analyzed and the issue was able to be confirmed.Upon examination, it was observed that the top cover and front panel both exhibit finish damage.Product analysis was unable to reproduce or duplicate the customer's initial complaint.However, the investigation revealed an unexpected issue.An unknown liquid oxidized the interior chassis and dried onto the catheter interface contacts, as well as the socket assembly.Furthermore, multiple video connection errors were identified in the error logs.It is highly probable that the unknown contamination is the root cause of both the video issue and error experienced by the customer during the procedure.The issue is unlikely related to manufacturing, as product analysis identified issues related to use and maintenance and did not identify any manufacturing defect.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.Based on all gathered information, the conclusion code assigned to this investigation is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: EXALT CONTROLLER
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18093409
• MDR Text Key: 327899317
• Report Number: 3005099803-2023-06116
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: 08714729990901
• 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,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2005201277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1