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	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt b monitor kit was used during an unknown procedure performed on an unknown date.Despite a battery charge of 100%, the monitor powered off intermittently causing visualization to be lost during the procedure.No further information has been able to be obtained despite good faith efforts.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.H6: device code a06 captures the reportable event of loss of visualization inside the patient.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the exalt model b monitor kit was inspected and analyzed.Product analysis was not able to replicate the reported event and the device functioned correctly throughout analysis.It is possible that the reported event could be caused by disconnecting the power cord, or by not fully charging the unit before use, however, the reported complaint could not be confirmed.Although product analysis was unable to replicate the failure, an analysis of the log files was performed, and no issues were encountered as the device was able to run on battery exclusively a period of time well within the recommended timeframe.The power supply was disconnected from the unit and tested with the single use device (sud).The analysis of the log files revealed that when the system is first plugged into an external monitor the screen displays black momentarily during refresh and then displays the image.Additionally, when the system is idle without any sud connected, the unit enters screen saver mode.Based on all gathered evidence, the cause code selected is no problem detected, which indicates that the reported event was not able to be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.Block h11: block e2 has been corrected to yes.Block e3 has been corrected to other healthcare professional.Block g2 has been corrected to company representative, health professional.
Event or Problem Description
It was reported to boston scientific corporation that an exalt b monitor kit was used during an unknown procedure performed on an unknown date.During the procedure, the monitor powered off intermittently.No further information has been able to be obtained despite good faith efforts.

• 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: 17577516
• Report Number: 3005099803-2023-04490
• Device Sequence Number: 8877187
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 0022307030
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/18/2023
• 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