BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PLASMA PADDLE BLADE

    MDR report key: 10493877 · Received September 3, 2020

    Report

    Report Number
    MW5096431
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 6, 2020
    Manufacturer
    US MEDICAL INNOVATIONS, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF PLASMA BLADE CAUTERY CAME OFF - FOUND IN A RAYTEC. DATE OF USE: (B)(6) 2020. DIAGNOSIS OR REASON FOR USE: RIGHT TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956712 CANADY HYBRID PLASMA PADDLE BLADE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS, LLC PB-42255 0055-S555-20

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR