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

Model Number	M00542711
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b single use bronchoscope, slim, was used during an unknown procedure on (b)(6) 2023.Additional information received on july 5, 2023, indicated that the exalt b scope's image flickered and subsequently became lost while the scope was inside the patient.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b single use bronchoscope, slim, was used during an unknown procedure on (b)(6) 2023.Additional information received on july 5, 2023, indicated that the exalt b scope's image flickered and subsequently became lost while the scope was inside the patient.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: the returned exalt model b scope was visually inspected and analyzed.An x-ray inspection was performed to inspect electronics and no issues were observed with the camera wire, solder, or electrical components in the device umbilicus, handle, or shaft.Electrical and resistance testing at the umbilicus connector was conducted and no issues were identified.An image test was done by connecting the umbilicus to a monitor.A live, clear image was displayed.The device was articulated using the handle knob and no change to the live image was observed.Tension was applied to the umbilicus connector, 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.The device log was downloaded from the monitor, it was confirmed that the scope was successfully connected to a monitor on (b)(6) 2023.Product analysis could not replicate the reported event.The image functioned correctly throughout product analysis.The device log showed that the device was used during the procedure for approximately 4 hours.Based on the information available, 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: blocks g1, d4, h4 have been updated based on the product analysis.

• 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 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17315343
• Report Number: 3005099803-2023-03809
• Device Sequence Number: 4058174
• Product Code: EOQ
• UDI-Device Identifier: 00191506007430
• UDI-Public: 00191506007430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 11/30/2023
• Device Model Number: M00542711
• Device Catalogue Number: 4271
• Device Lot Number: 0030625190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown