BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA ELITE SYSTEM CONTINUOUS FLOW INNER SHEATH

    MDR report key: 3122159 · Received May 17, 2013

    Report

    Report Number
    1519132-2013-00011
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE TIP OF THE UNIT BROKE INSIDE THE PT. THE SURGEON DID THE BEST HE COULD TO RETRIEVE ALL PIECES, BUT THERE MAY BE SMALL FRAGMENTS THAT REMAINED BEHIND. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219687 USA ELITE SYSTEM CONTINUOUS FLOW INNER SHEATH CONTINUOUS FLOW INNER SHEATH HIH GYRUS ACMI, INC. EIS-HCF27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other