BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING OF RESECTOSCOPE INNER SHEATH

    MDR report key: 4655624 · Received March 27, 2015

    Report

    Report Number
    2951238-2015-00142
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    GRUS AMCI INC.
    Product Code
    FJL
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF THE BLADDER (TURB) PROCEDURE, THE TIP OF THE SCOPE BROKE OFF INSIDE THE PT. THE SURGEON USED A GRASPER AND SUCCESSFULLY RETRIEVES THE DEVICE FRAGMENT FROM THE BLADDER. THE INTENDED PROCEDURE WAS COMPLETED W/ THE SAME DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205402 ROTATING OF RESECTOSCOPE INNER SHEATH RESECTOSCHOPE INNER SHEATH FJL GRUS AMCI INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1