MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. ALPHA OMEGA; STERILE DISPOSABLE CANNULA FOR MER

Model Number	Standard
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident was reported by "department of neurosurgery, (b)(6) university" in (b)(6) (the customer), which uses alpha omega engineering's (aoe) neuro omega system for navigation during neurosurgery for placement a dbs electrode.Aoe's cannula p/n-str-007721-10, with length 177 mm, is normally used for this neurosurgery procedure.In the reported incident, a longer identical cannula was mistakenly used (p/n- str-020121-10, with length 201.5 mm), resulting a dipper insertion, before the mistake was realized by the customer.The two types of cannulas are used by the customer's for different head frames.The label on the cannula clearly identifies the cannula type (by part number, length and diameter).No injury medical intervention to the patient was reported by customer.

• Brand Name: ALPHA OMEGA
• Common Device Name: STERILE DISPOSABLE CANNULA FOR MER
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; mount precipice; nazareth, 16121 02; IS 1612102
• MDR Report Key: 7780725
• Report Number: 9615126-2018-00002
• Device Sequence Number: 1938611
• Product Code: GZL
• UDI-Device Identifier: 07290014954694
• UDI-Public: (01)07290014954694(17)191025(10)29713
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: Standard
• Device Catalogue Number: STR-020121-10
• Device Lot Number: 29713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other