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	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in january 2024.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6 (device codes): 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 monitor was used with an exalt model b scope, regular during an unknown procedure performed on an unknown date.During the procedure, the monitor screen went black and visualization was lost.The physician switched to a second exalt model b monitor and a new exalt model b scope to complete the procedure.There were no reported patient complications as a result of this event.Note: this report pertains to one of four devices used (three scopes and one monitor).Refer to manufacturer report number 3005099803-2024-00540 for the first exalt model b scope, 3005099803-2024-00541 for the second exalt model b scope, 3005099803-2024-00542 for the third exalt model b scope and 3005099803-2024-00478 for the exalt model b monitor.

• 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; coyol ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18738477
• Report Number: 3005099803-2024-00540
• Device Sequence Number: 17737444
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: M00542731
• Device Catalogue Number: 4273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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