BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA OMEGA

    MDR report key: 7780725 · Received August 14, 2018

    Report

    Report Number
    9615126-2018-00002
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 7, 2018
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    UDI-DI
    07290014954694
    PMA / PMN Number
    K120098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623929 ALPHA OMEGA STERILE DISPOSABLE CANNULA FOR MER GZL ALPHA OMEGA ENGINEERING LTD. Standard 29713 07290014954694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other