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

Model Number	M00542760
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b monitor kit was used during a bronchoscopy procedure for bronchial inspection and cleaning under local anesthesia on an unknown date.During the procedure, the exalt model b monitor stopped working causing visualization to be lost.The procedure was not able to be completed as a result of this event.The procedure was completed the next day with a reusable scope.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 09/01/2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 09/11/2023.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

• Brand Name: EXALT B MONITOR
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TRICE MEDICAL INC; 40 general warren blvd; suite 100; malvern PA 19355
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17876540
• Report Number: 3005099803-2023-05327
• Device Sequence Number: 4450232
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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 Model Number: M00542760
• Device Catalogue Number: 2295-05
• Device Lot Number: 0021347025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown