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

Model Number	M00542731
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated date based on the date 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.
Event or Problem Description
It was reported to boston scientific corporation that a regular exalt model b scopes was used during a bedside bronchoscopy performed on an unknown date.After five minutes of use, the scope's image was lost.The procedure was unable to be completed as a result of this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated date based on the date 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 h10: the device exalt model b scope was analyzed.The device returned with no visual damages, and after an image test conducted by connecting the umbilicus to a monitor, the single use device error screen appeared as expected.After disassembling the device, it was found that the hot bar solder pads were not properly welded.This can lead to a malfunction of the scope by causing no visualization upon plugging the scope into monitor.Based on the evidence, the event can be confirmed.Additionally, four photos provided by the complainant were reviewed and it was seen that the device's capital equipment did not show any images from the camera on the screen.With all gathered information, boston scientific concludes that the most probable cause for this event is manufacturing deficiency as evidenced by the improper welding of hot bar solder pads.An investigation to address this problem is in progress.
Event or Problem Description
It was reported to boston scientific corporation that a regular exalt model b scopes was used during a bedside bronchoscopy performed on (b)(6) 2023.After five minutes of use, the scope's image was lost.The procedure was unable to be completed as a result of this event.There were no patient complications reported as a result of this event.

• Brand Name: EXALT MODEL B SINGLE USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18505068
• Report Number: 3005099803-2023-07150
• Device Sequence Number: 18129790
• Product Code: EOQ
• UDI-Device Identifier: 00191506007461
• UDI-Public: 00191506007461
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/14/2024

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 Expiration Date: 10/01/2024
• Device Model Number: M00542731
• Device Catalogue Number: 4273
• Device Lot Number: 0032525649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown