BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU® NEUTRALECT-MINI ELECTROSURGICAL NEUTRAL ELECTRODE

    MDR report key: 6145641 · Received December 5, 2016

    Report

    Report Number
    9610691-2016-00007
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 5, 2016
    Manufacturer
    AMBU A/S
    Product Code
    GEI
    PMA / PMN Number
    K944817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS PROVIDED VERY LITTLE INFORMATION TO AMBU REGARDING THE INCIDENT DESPITE FOLLOW-UP ATTEMPTS. NO DETAILS REGARDING THE MACHINE SETTINGS , PROCEDURE OR APPLICATION OF THE DEVICE HAS BEEN PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, NEITHER HAS PICTURES OR LOT NO. BEEN PROVIDED. DUE TO LIMITED INFORMATION, IT IS DIFFICULT TO VERIFY THE REPORTED FAILURE AND THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE IDENTIFIED. INSTRUCTION FOR USE CONTAINS INFORMATIONS ON PLACEMENT ON THE ELECTRODES, RELATED TO BOTH WHERE TO PLACE THE ELECTRODE AND HOW TO APPLY IT, TOGETHER WITH CAUTIONS RELATED TO RISK IF INSTRUCTIONS ARE NOT IS NOT FOLLOWED. IT IS PRESUMED THAT IF THE DEVICE HAD BEEN USED ACCORDING TO THE INSTRUCTIONS THE INCIDENT WOULD HAVE BEEN UNLIKELY TO HAPPEN. HOWEVER AS VERY SPARSE INFORMATION HAS BEEN PROVIDED IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 1

    BURN RELATED TO ELECTROSURGICAL NEUTRAL ELECTRODES DURING ELECTRO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795420 AMBU® NEUTRALECT-MINI ELECTROSURGICAL NEUTRAL ELECTRODE ELECTROSURGICAL NEUTRAL ELECTRODES GEI AMBU A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other