BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA

    MDR report key: 3455682 · Received November 1, 2013

    Report

    Report Number
    MW5032583
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    HALT MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN MANIPULATING ACESSA HANDPIECE IN PATIENT. DURING MANIPULATION, INNER METAL HANDPIECE SNAPPED. PLASTIC SURROUNDING SHEATH. REMAINS INTACT ACESSA HANDPIECE REMOVED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563470 ACESSA ACESSA GEI HALT MEDICAL INC. T130301

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR