BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM

    MDR report key: 19804983 · Received July 23, 2024

    Report

    Report Number
    19804983
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    February 15, 2024
    Report Date
    February 23, 2024
    Manufacturer
    ALPHA OMEGA ENGINEERING CO. LTD.
    Product Code
    GZL
    UDI-DI
    07290114063340
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046239 STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM ELECTRODE, DEPTH GZL ALPHA OMEGA ENGINEERING CO. LTD. STR-S07721-00 79594 07290114063340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown