BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PLASMA PADDLE BLADE

    MDR report key: 16831909 · Received April 27, 2023

    Report

    Report Number
    MW5117084
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Report Date
    April 12, 2023
    Manufacturer
    US MEDICAL INNOVATIONS, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF HANDPIECE FALLS ¿OFF¿ DURING USE. COMPANY STATED THEY WERE CORRECTING ISSUE ABOUT ONE YEAR AGO. THE NUMBER OF INCIDENCES HAVE DECREASED IN THE LAST YEAR BUT ISSUE CONTINUES. (6 OCCURRENCES FROM MAY 2022- MARCH 2023). REFERENCE REPORT: MW5117085, MW5117086, MW5117087, MW5117088, MW5117089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566042 CANADY HYBRID PLASMA PADDLE BLADE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS, LLC 0143-5554-22

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown