MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING CO. LTD. STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM; ELECTRODE, DEPTH

Model Number	STR-S07721-00
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Wrong cannula was opened and placed into the brain while patient was awake, but patient showed no adverse effects.It was discovered by an x-ray taken to confirm placement that the cannula had gone too deep.Staff was unaware that there were two types of cannulas both labeled 15mm to target available.One is newly on the shelf that is specifically made for one type of procedure.It was not clearly marked that they were different.On the right-hand side of the product packages, there is length typed, but it is not in the main label description.Packages are almost identical.This is a huge safety risk, and we suggest revision of packaging.

• Brand Name: STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM
• Common Device Name: ELECTRODE, DEPTH
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING CO. LTD.; 3160 campus drive; suite.200; norcross GA 30071
• MDR Report Key: 19804983
• Report Number: 19804983
• Device Sequence Number: 20679306
• Product Code: GZL
• UDI-Device Identifier: 07290114063340
• UDI-Public: (01)07290114063340
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2024
• Report Date (Section F): 02/23/2024

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: STR-S07721-00
• Device Catalogue Number: STR-S07721-00
• Device Lot Number: 79594
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• 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: 02/23/2024