BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID

    MDR report key: 17566052 · Received August 16, 2023

    Report

    Report Number
    MW5144685
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 14, 2023
    Manufacturer
    US MEDICAL INNOVATIONS, LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE BEING PERFORMED WAS A TOTAL HIP ARTHROPLASTY. THE PLASMA CANADY TIP CRACKED WHILE IN USE DURING THE PROCEDURE. THE WHITE PIECE THAT BROKE OFF WAS APPROX 2MM IN SIZE. SURGEON LOOKED FOR MISSING PIECE AND UNABLE TO FIND IT. ENTIRE AREA WAS IRRIGATED WITHOUT LOCATING THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760258 CANADY HYBRID ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS, LLC. 0263-S555-22

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female