BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CONTINUOUS FLOW RESECTOSCOPE SHEATH

    MDR report key: 4143608 · Received August 21, 2014

    Report

    Report Number
    2951238-2014-00345
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    August 5, 2014
    Manufacturer
    GYRUS AMCI INC
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 PROSTATE RESECTION PROCEDURE, THE TIP OF THE DEVICE BROKE OFF AND FELL INTO THE PT'S BLADDER. THE BROKEN TIP WAS RETRIEVED FROM THE PT. NO PT INJURY WAS REPORTED. OLYMPUS MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFO BUT NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506087 ROTATING CONTINUOUS FLOW RESECTOSCOPE SHEATH RESECTOSCOPE INNER SHEATH FJL GYRUS AMCI INC ERIS-CF25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1