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	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: problem 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 single-use bronchoscope, regular was used in a bronchoscopy performed on (b)(6).2023.During the bronchoscopy, while the scope was inserted in the patient, the scope error message appeared and then image was regained for a brief period before visualization to the exalt b monitor was completely lost and could not be regained.The physician then removed the scope from the patient.The procedure was successfully completed using another single-use bronchoscope.There were no reported patient complications as result of this event.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18141346
• Report Number: 3005099803-2023-06222
• Device Sequence Number: 7998872
• Product Code: EOQ
• UDI-Device Identifier: 00191506007461
• UDI-Public: 00191506007461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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: 06/01/2024
• Device Model Number: M00542731
• Device Catalogue Number: 4273
• Device Lot Number: 0031826802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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