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

Model Number	M00542430
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04627 for the exalt model d scope and report number 3005099803-2024-04626 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt model d controller during an unknown procedure on an unknown date.During the procedure, the screen showed an error screen and visualization was lost.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block b3: approximated based on the date the manufacturer became aware of the event.Block h11: the returned exalt model d controller was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.The investigation was unable to identify any damage or malfunction related to the reported event.Based on all gathered information, the probable cause selected is no problem detected, which indicates that the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04627 for the exalt model d scope and report number 3005099803-2024-04626 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt model d controller during an unknown procedure on an unknown date.During the procedure, the screen showed an error screen and visualization was lost.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: EXALT CONTROLLER
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 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: 20257183
• Report Number: 3005099803-2024-04626
• Device Sequence Number: 12653343
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: 08714729990901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2113700031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown