BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PADDLE BLADE (HANDLE & 85MM TIP)

    MDR report key: 7221031 · Received January 26, 2018

    Report

    Report Number
    7221031
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 17, 2018
    Report Date
    January 24, 2018
    Manufacturer
    CANADY BIOTECHNOLOGY, LLC FOR US MEDICAL INNOVATIONS, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON STATED, "I WAS USING IT LIKE I NORMALLY DO, AND AT SOME POINT DURING THE PROCEDURE, IT STARTED TO ALARM OFF AND ON, AND WOULD WORK INTERMITTENTLY. THEY CHANGED THE GROUNDING PAD TWICE WHICH HELPED TEMPORARILY. AFTER THE SECOND PAD CHANGE, I WAS USING IT AND I THOUGHT THE TIP WAS COMING UNSCREWED, AS IT SOMETIMES DOES, BUT INSTEAD THAT'S WHEN I NOTICED THAT IT HAD ACTUALLY MELTED IN HALF BELOW THE THREADS WHERE THE TIP ATTACHES AND HAD OBVIOUSLY OVER-HEATED. IT WASN'T AN INORDINATE AMOUNT OF USE. I HAVE HAD THE UNIT WORK INTERMITTENTLY AND MAKE ALARM NOISES A FEW TIMES, BUT I HAVE NEVER SEEN IT SELF-DESTRUCT SO TO SPEAK LIKE THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64874 CANADY HYBRID PADDLE BLADE (HANDLE & 85MM TIP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CANADY BIOTECHNOLOGY, LLC FOR US MEDICAL INNOVATIONS, LLC PB-422555 0198-S555-17

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR YES, THE CANADY BLADE / GENERATOR.SERIAL (B)(4)