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

Model Number	M0054276Z0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: problem code a06 captures the reportable event of loss of visualization inside the patient.Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, june 23, 2023.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-03794 for the exalt model b scope.It was reported to boston scientific corporation that an exalt model b monitor kit was used during an unknown procedure on an unknown date.It was reported that during the procedure the image of the exalt model b scope flickered and then it was lost.The image was able to be regained after unplugging and re-plugging the scope into the exalt model b monitor.The procedure was able to be completed with the same exalt b scope and monitor.There were no complications as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-03802 for the exalt model b scope.It was reported to boston scientific corporation that an exalt model b monitor kit was used during an unknown procedure on an unknown date.It was reported that during the procedure the image of the exalt model b scope flickered and then it was lost.The image was able to be regained after unplugging and re-plugging the scope into the exalt model b monitor.The procedure was able to be completed with the same exalt b scope and monitor.There were no complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: problem code a06 captures the reportable event of loss of visualization inside the patient.Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2023.Block h10: the exalt model b monitor kit was inspected and analyzed.Product analysis was unable to replicate the reported issue.Therefore, the reported complaint could not be confirmed.Although product analysis was unable to replicate the failure, an analysis of the device log files found an intermittent issue connecting to single use devices (suds) and narrowed the field of potential root causes to the scope connection port, internal hardware failures, or internal connections between electronics in the unit.Product analysis was unable to fully isolate the error to any specific hardware component, as the intermittent problem could not be replicated during the time spent testing.The failure is considered a random component failure, as the issue presented after extended use during the life cycle of the product, indicating it is unlikely an issue traced to manufacturing or production.Based on the investigation findings, the cause code selected is cause traced to component failure, which indicates that the failure was an expected or random failure with no relation to design or manufacturing.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 b5 has been corrected.

• 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: 17305864
• Report Number: 3005099803-2023-03764
• Device Sequence Number: 12433606
• Product Code: EOQ
• UDI-Device Identifier: 00191506007843
• UDI-Public: 00191506007843
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/22/2023

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: M0054276Z0
• Device Catalogue Number: 2295-05
• Device Lot Number: 0022144024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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