BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    882.4360

    MDR report key: 2755487 · Received September 19, 2012

    Report

    Report Number
    1045834-2012-00018
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT. ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED, A FOLLOW UP WILL BE PROVIDED.

    Description of Event or Problem · 1

    DEVICE WAS BEING USED IN AN EAR CASE. DURING SURGERY PERSONNEL OBSERVED FLUID DRIPPING OUT OF TIP AND THEN SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 882.4360 EMAX2 PLUS SYSTEM HBE THE ANSPACH EFFORT, INC. EMAX2 PLUS MOTOR

    Patients

    Seq Age Sex Outcome Treatment
    1