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	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2024.Block h6 (device codes): problem code (b)(6) 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 during the same procedure (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.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-00540 for the exalt model b scope, and 3005099803-2024-00478 for the exalt model b monitor.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.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2024.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: correction made to b5.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in january 2024.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: the returned exalt model b monitor was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed however, the monitor's device usage logs were reviewed, and it was noted that an expired exalt model b scope was attempted for use several times.Additionally, the monitor was left to fully discharge and four attempts were made to use the device before allowing the battery to charge.Based on the information available, the reported event was unable to be confirmed.Since the investigation was unable to identify any damage or malfunction related to the reported allegation, the investigation conclusion code selected for the complaint is no problem detected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-00540 for the exalt model b scope, and 3005099803-2024-00478 for the exalt model b monitor 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.

• 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: 18748150
• Report Number: 3005099803-2024-00478
• Device Sequence Number: 19758765
• Product Code: EOQ
• UDI-Device Identifier: 00191506007836
• UDI-Public: 00191506007836
• 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,Followup,Followup
• Report Date (Section B): 07/10/2024

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: 0022307046
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 01/23/2024; 06/21/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 02/22/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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