MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL B SINGLE USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00542731
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2023.Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b scope, regular was used on a bronchoscopy procedure on unknown date.It was reported that during the procedure the image of the exalt b scope was lost.The scope was exchanged for another exalt model b scope, and the procedure was able to be completed.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b scope, regular was used on a bronchoscopy procedure on an unknown date.It was reported that during the procedure the image of the exalt b scope was lost.The scope was exchanged for another exalt model b scope, and the procedure was able to be completed.No patient complications were reported as a result of this event.Additional information received on november 16, 2023: download of device log confirms that the exalt model d scope was used on (b)(6) 2023.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 09/15/2023.Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model b single use bronchoscope was analyzed, and product analysis was unable to identify any damage or defect.An x ray inspection was performed to inspect the device electronics.No device issues were observed with the camera wire, solder, or electrical components in the device umbilicus, handle, or shaft.Visual inspection of the device revealed no damage to the umbilicus, handle, shaft, or tip.An image test was conducted by connecting the umbilicus to a monitor and a live, clear image was displayed.The device was articulated using the handle knob and no change to the live image was observed.Manipulation to the connector was performed and it remained firmly seated in the monitor, and no change to the live image was observed.The image was stable for several minutes throughout device manipulation and never experienced an issue.Product analysis could not replicate the reported event.The image functioned correctly throughout analysis.The device log showed the device was used during the procedure for approximately 4 hours on (b)(6) 2023.With all the available information, the conclusion code assigned to this investigation is no problem detected, which indicates that a reported event could not be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: b3, b5 updated based on additional information downloaded from device log on november 16, 2023.

• Brand Name: EXALT MODEL B SINGLE USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2456 calle primera; alajuela IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17876779
• Report Number: 3005099803-2023-05341
• Device Sequence Number: 4320610
• Product Code: EOQ
• UDI-Device Identifier: 00191506007461
• UDI-Public: 00191506007461
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K211030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: M00542731
• Device Catalogue Number: 4273
• Device Lot Number: 0030030517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown