MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. NEUROPROBE; ELECTRODE, DEPTH

Model Number	NEUROPROBE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Supply was tested by surgeon before using it on patient and supply was found to be "manufactured incorrectly.".

• Brand Name: NEUROPROBE
• Common Device Name: ELECTRODE, DEPTH
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; 3160 campus drive suite.200; norcross GA 30071
• MDR Report Key: 20609491
• Report Number: 20609491
• Device Sequence Number: 17978416
• Product Code: GZL
• UDI-Device Identifier: 07290014954946
• UDI-Public: (01)07290014954946(17)260716(10)87976
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024
• Report Date (Section F): 09/17/2024

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: NEUROPROBE
• Device Catalogue Number: STR-AP9080-00
• Device Lot Number: 87976
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/17/2024