BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CONTINUOUS FLOW INNER SHEATH

    MDR report key: 4071882 · Received August 12, 2014

    Report

    Report Number
    2951238-2014-00332
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE I THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE PLASTIC PIECE ON THE TIP OF THE INNER SHEATH BROKE OFF AND FELL INSIDE THE PATIENT. THE PLASTIC PIECE WAS RETRIEVED FROM THE PT. THERE WAS NO INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE IN AN EFFORT TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478988 ROTATING CONTINUOUS FLOW INNER SHEATH INNER SHEATH FDS GYRUS ACMI INC. GERIS-CF25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other