BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRA-I CS RETRACTOR BODY

    MDR report key: 4122010 · Received September 19, 2014

    Report

    Report Number
    2242352-2014-01016
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE MIRA-I CS RETRACTOR BODY WAS BEING DEMONSTRATED TO A SURGEON IN A NONSTERILE ENVIRONMENT. THE SALES REPRESENTATIVE DISCOVERED A FLAW IN THE RETRACTOR BODY THAT WILL NEED REPLACING. THE SCREW THAT ENABLES THE BLADE TO WIDEN ON THE RIGHT BLADE IS COMING ALL OF THE WAY OUT OF THE RETRACTOR. IT IS SUPPOSED TO HAVE A "STOP" POINT, BUT IT APPEARS AS THOUGH IT HAS BEEN DAMAGED AND WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583172 MIRA-I CS RETRACTOR BODY CLAMP-LESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC MS-0104

    Patients

    Seq Age Sex Outcome Treatment
    1