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 02/01/2024

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-00770 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.

Manufacturer Narrative

B3: the exact date of the event is unknown.The provided event date, (b)(6) 2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2024.H6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

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 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 the customer's complaint was verified.Device analysis: the controller and single-use device (sud) assembly is damaged by fluid ingress.The light engine requires new catheter contacts and socket assembly.The controller also requires a rebuild to repair.A discolored connector socket is observed and there's evidence of fluid ingress and cover seams.Labeling review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Risk review: a risk review was completed and confirmed that the event of loss of visualization was defined in the risk documentation and is documented accordingly in the prr table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: according to the report provided, the console was damaged by fluid ingress.It is likely that the fluid ingress evidence is a result of cleaning solution getting into the housing and contacting the internal components.Therefore, based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.

Event Description

It was reported to boston scientific corporation that an exalt model d controller was used during an unspecified procedure on an unknown date.Through 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, 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 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: 18838488
• MDR Text Key: 336912729
• Report Number: 3005099803-2024-00770
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Model Number: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2031700038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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