BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM

    MDR report key: 20144947 · Received September 5, 2024

    Report

    Report Number
    3003172841-2024-08006
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    February 15, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    UDI-DI
    07290114063340
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A CASE IN MAYO CLINIC HOSPITAL, ROCHESTER MN A WRONG CANNULA WAS CHOSEN, STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM CAT# STR-S07721-00 SHOULD BE PICKED UP INSTEAD OF AN ALTERNATIVE CANNULA DEDICATED FOR STARFIX STEREOTACTIC FRAME CAT# STR-S20121-00. BOTH CANNULA ARE DEFINED AS 15MM ABOVE TARGET, BUT THE LENGTH IS DIFFERENT, ALL DIMENSIONS ARE MENTIONED IN ALL LABELS, SINGLE PACK LABEL AND POUCH LABEL, BUT THE HEALTH PROFESSIONAL LOOKED FOR THE DEFINITION OF ABOVE TARGET IN MM, AND DIDN'T VERIFY THE CANNULA LENGTH. AFTER A X-RAY WAS TAKEN DURING THE DBS PROCEDURE, IT WAS OBSERVED THAT THE CANNULA IS LONGER THEN PLANNED AND POSITIONED DEEPER THAN PLANNED. NO CLINICAL SYMPTOMS WERE OBSERVED ON THE PATIENT. THE FACILITY DIDN'T REPORT TO US ON THIS EVENT, ONLY TO THE FDA, AS WE RECEIVED AND MDR REPORT FROM THE FDA. THE FACILITY MENTIONED ALPHA OMEGA ENGINEERING CO. LTD. WITH ITS ADDRESS : 3160 CAMPUS DRIVE, SUITE. 200, NORCROSS, GA US 30071, BUT THIS COMPANY IS OUR IMPORTER AND FDA AGENT. ALPHA OMEGA ENGINEERING LTD. LOCATED IN ISRAEL IS THE MANUFACTURER OF THE SUSPECT DEVICE. ALPHA OMEGA ENGINEERING CO. LTD REPRESENTATIVE IN US WAS IN TOUCH WITH THE HOSPITAL'S NEUROSURGEON AND VERIFIED THIS SITUATION. ALPHA OMEGA ENGINEERING LTD. WILL IMPLEMENT ADDITIONAL DEVICE DESCRIPTION FIELD ON THE POUCH LABEL TO PREVENT ANY CONFUSION BETWEEN BOTH CANNULA.

    Description of Event or Problem · 0

    DURING A DBS CASE IN MAYO CLINIC HOSPITAL -ROCHESTER, MN A WRONG CANNULA WAS CHOSEN, PLEASE SEE THE HOSPITAL'S PATIENT SAFETY SPECIALIST DESCRIPTION BELOW: 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
    2140748 STERILE CANNULA, 15 MM ABOVE TARGET, LENGTH 177MM ELECTRODE, DEPTH GZL ALPHA OMEGA ENGINEERING LTD. STR-S07721-00 79594 07290114063340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown