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	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.H6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01043 for the exalt model b scope.It was reported to boston scientific corporation that an exalt model b single use bronchoscope was used during a bronchoscopy procedure on an unknown date.During the procedure, the exalt model b monitor lost image.The screen went blank.The medical staff confirmed that the power supply cord was connected to the monitor during the event.Therefore, a second monitor was used to complete the procedure.It is unknown if the same exalt model b scope was used with the second monitor.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: upon return of this device, it was thoroughly analyzed.Analysis of the device was unable to replicate the reported allegations.No problem was detected with the unit that could have cause or contributed with the event.The returned exalt model b monitor was analyzed and exhibited normal device characteristics.The device passed all tests performed except the battery health test.The full charge capacity is smaller than the minimum charge capacity.The reported event was not confirmed.Analysis was unable to replicate the loss of visualization.A defective camera, which was not returned for investigation, is a probable cause for the event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01043 for the exalt model b scope.It was reported to boston scientific corporation that an exalt model b single use bronchoscope was used during a bronchoscopy procedure on an unknown date.During the procedure, the exalt model b monitor lost image.The screen went blank.The medical staff confirmed that the power supply cord was connected to the monitor during the event.Therefore, a second monitor was used to complete the procedure.It is unknown if the same exalt model b scope was used with the second monitor.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).

• 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: 18903335
• Report Number: 3005099803-2024-01044
• Device Sequence Number: 9136114
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/23/2024

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: M00542760
• Device Catalogue Number: 2295-05
• Device Lot Number: 0022339119
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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