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

Model Number	M00542760
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code e2330 pain is being used to capture minor injury to staff member.There was no patient injury.Device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter overheating.
Event or Problem Description
It was reported that an exalt model b monitor was used during a bronchoscopy performed on (b)(6) 2024, for bronchial lavage.During preparation for the procedure, a staff member noticed that the ac power adapter for the monitor was hot to the touch and almost melting.They unplugged the power cable from the monitor and the wall outlet, and completed the procedure using the exalt b monitor unplugged.There were no patient complications as a result of this event.The staff member who handled the ac power adapter reported experiencing minor pain from the heat.
Additional Manufacturer Narrative
Patient code e2330 pain is being used to capture minor injury to staff member.There was no patient injury.Device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter overheating h2 correction: tab g manufacturing site.Block h11: with all the available information, boston scientific concludes that the reported event was confirmed.Examination of the device identified tears in the ac input cord and green tarnishing of the copper wires.It is probable that the cable was dragged across a sharp edge.Tarnishing of the copper could be from cleaning fluids in the hospital, heat due to the current being drawn over the few remaining strands of wire, or a combination of the two.Overheating could have been caused as strands of wire broke, the voltage drops increased and the current draw increased to power the device.The device instructions for use (ifu) instructs to inspect the monitor and cables for damage.It also states not to use a component if it appears damaged.The returned power adaptor was analyzed.Visual examination of the device identified minor scuffing of the housing screen.The examination of the cord identified two tears and a dent.One tear was located 20 inches from the connector tip.A major tear was located at 23 inches from the connector tip.A smaller dent was located at 25 inches from the connector tip.The damage is consistent with pressure over a sharp edge multiple times.Green tarnishing of the copper wires was observed.A labeling review was performed.The ifu includes specific warnings/instructions such as: inspect the monitor and cables for damage.Do not use if package is opened or damaged.Do not use if labeling is incomplete or illegible.Do not use a component if it appears damaged.Based on all gathered information, the probable cause selected for reported overheating of the power adaptor is unintended use error.
Event or Problem Description
It was reported that an exalt model b monitor was used during a bronchoscopy performed on (b)(6) 2024, for bronchial lavage.During preparation for the procedure, a staff member noticed that the ac power adapter for the monitor was hot to the touch and almost melting.They unplugged the power cable from the monitor and the wall outlet, and completed the procedure using the exalt b monitor unplugged.There were no patient complications as a result of this event.The staff member who handled the ac power adapter reported experiencing minor pain from the heat.

• 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: 18970981
• Report Number: 3005099803-2024-01250
• Device Sequence Number: 17762155
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 0021138034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown