MAUDE Adverse Event Report: IMRIS Imaging, Inc. NEURO II-SE, MODELS: OR-DR-OR, OR-MB

Model Number	105000-003
Medical Device Problem Codes	Device Damaged by Another Device (2915); Failure to Auto Stop (2938); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• Brand Name: NEURO II-SE, MODELS: OR-DR-OR, OR-MB
• Common Device Name: Neuro II-SE
• Manufacturer (Section D): IMRIS Imaging, Inc.; 1230 chaska creek way; sutie 100; chaska MN 55318
• Manufacturer (Section G): IMRIS Imaging, Inc.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: stacy kramer ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; +1(763)203-6338
• MDR Report Key: 50417088
• Report Number: 3010326005-2026-00007
• Device Sequence Number: 10461648
• Product Code: LNH
• UDI-Device Identifier: 00857534006929
• UDI-Public: (01)00857534006929(11)20111114
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K071099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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
• Device Model Number: 105000-003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown