MAUDE Adverse Event Report: MicroAire Surgical Instruments MicroAire SmartRelease; Autoclavable Endoscope

Model Number	81025
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: MicroAire SmartRelease
• Common Device Name: Autoclavable Endoscope
• Manufacturer (Section D): MicroAire Surgical Instruments; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer (Section G): MicroAire Surgical Instruments; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer Contact: christina weiss ; 3590 grand forks blvd; charlottesville, VA 22911 ; +1(434)975-8360
• MDR Report Key: 50108379
• Report Number: 2020601-2026-00007
• Device Sequence Number: 18831618
• Product Code: HRX
• UDI-Device Identifier: 00847399017253
• UDI-Public: (01)00847399017253(11)260513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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 Model Number: 81025
• Device Catalogue Number: 81025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown