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 02/27/2024

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01035 for the exalt model d scope.It was reported that and exalt model d controller 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 controller would not power on.The account switched to a reusable scope to complete the procedure.There were no patient complications related to this event.

Manufacturer Narrative

H6: device code a06 captures the reportable event of loss of visualization inside the patient.

Manufacturer Narrative

Block h6: device 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 allegation of loss of visualization was unable to be confirmed.Upon receipt of this device, the controller was thoroughly analyzed.Visual analysis identified finish damage to the top cover, front panel, and bottom of housing.During functional testing, the device performed as intended.The reported observation was not able to be duplicated or confirmed.Based on all gathered information, the probable cause selected for loss of visualization is no problem detected, which indicates that the device problem was not confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01035 for the exalt model d scope.It was reported that and exalt model d controller 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 controller would not power on.The account switched to a reusable scope to complete the procedure.There were no patient complications related to 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: 18941033
• MDR Text Key: 338901843
• Report Number: 3005099803-2024-01173
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Model Number: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2005201340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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