BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PLASMA SCALPEL

    MDR report key: 10836668 · Received November 12, 2020

    Report

    Report Number
    MW5097837
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 21, 2020
    Report Date
    October 27, 2020
    Manufacturer
    US MEDICAL INNOVATIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING FIRST CLOSING COUNT OF PROCEDURE, STAFF NOTICED THAT TIP OF CANADY HAND PIECE WAS MISSING. PIECE WAS THEN FOUND ON MAYO STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298875 CANADY HYBRID PLASMA SCALPEL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS 37DJ2309

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other