MAUDE Adverse Event Report: Micro-Tech (Nanjing) Co.,Ltd. Areus Endobronchial Ultrasound Aspiration Needle; Bronchoscope Accessory

Catalog Number	EBUS00001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported during endobronchial ultrasound case, endobronchial ultrasound scope (b)(6) broke related to thoracent/areus endobronchial ultrasound aspiration needle.Scope working at beginning of case.Passed needle through channel, scope still working.Attempted to deploy needle and image on screen became pixelated.Removed needle and attempted to reinsert/redeploy, and pixelation on screen became worse.Pixelation on screen became worse with every attempt to redeploy needle.
Additional Manufacturer Narrative
After micro-tech received this incident, we reviewed the manufacturing documents from the device history record and found no abnormalities that would contribute to this issue.We are trying to get more informaiton for investigation.We will fill a follow-up report when this incident investigation is done.

• Brand Name: Areus Endobronchial Ultrasound Aspiration Needle
• Common Device Name: Bronchoscope Accessory
• Manufacturer (Section D): Micro-Tech (Nanjing) Co.,Ltd.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): Micro-Tech(Nanjing) Co.,Ltd.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, ind; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 50835423
• Report Number: 3004837686-2026-00010
• Device Sequence Number: 9949578
• Product Code: KTI
• UDI-Device Identifier: 16932503549216
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: k213060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Catalogue Number: EBUS00001
• Device Lot Number: M260403171
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White