BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS OES URETERO-RENO FIBERSCOPE

    MDR report key: 2885309 · Received November 21, 2012

    Report

    Report Number
    8010047-2012-00435
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THERE WAS NO PT HARM REPORTED WITH NO FURTHER DETAILS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THE USER'S REPORT. THERE WERE BURN MARKS FOUND ON THE INSERTION TUBE EXPOSED THE METAL BRAID INSIDE THE INSERTION TUBE. THE INSERTION TUBE FAILED THE LEAK TEST DUE TO THE DAMAGED METAL BRAID. THIS PHENOMENON WAS ATTRIBUTED TO MISHANDLING.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE REFERENCED DEVICE WAS DAMAGED WHEN A LASER WAS USED. THERE WAS NO FURTHER DETAIL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES URETERO-RENO FIBERSCOPE URETEROSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1