BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAST QUADRANT RECTRACTOR SYSTEM

    MDR report key: 1881974 · Received October 12, 2010

    Report

    Report Number
    1030489-2010-01319
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    GAD
    PMA / PMN Number
    K043602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION TO THE QUADRANT RETRACTOR LIGHT SOURCE GOT VERY HOT AND BURNED HOLES IN THE TOWEL THAT WAS WRAPPED AROUND IT. NO PT COMPLICATIONS WERE REPORTED IN THIS CASE. IN ADDITION, IT IS REPORTED THAT A HIGHER THAN 100 VOLTAGE POWER SOURCE WAS USED IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAST QUADRANT RECTRACTOR SYSTEM ILLUMINATION SYSTEM GAD MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1