BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CF RESECTOSCOPE INNER SHEATH

    MDR report key: 3760856 · Received April 7, 2014

    Report

    Report Number
    2951238-2014-00159
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 19, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE, THE WHITE CERAMIC TIP BROKE OFF INSIDE THE PT'S BLADDER. THE PT WAS TAKEN TO A LOCAL HOSPITAL TO REMOVE THE TIP. THE PHYSICIAN WAS UNSUCCESSFUL IN REMOVING THE TIP THROUGH THE URETHRA AND A TROCAR WAS USED TO ACCESS THE BLADDER WHERE THE TIP WAS REMOVED WITH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205689 CF RESECTOSCOPE INNER SHEATH RESECTOSCOPE FJL GYRUS ACMI INC. EIS-HCF25 ACI4035492

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R