BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF-RESECTION ELECTRODE

    MDR report key: 4071899 · Received August 12, 2014

    Report

    Report Number
    2951238-2014-00342
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 30, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    PMA / PMN Number
    K0120418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IN ADDITION, MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE DETAILED INFO REGARDING THE INCIDENT, BUT WITH NO RESULTS. IF ADDITIONAL INFO IS AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THREE RESECTION ELECTRODES BROKE OFF AND FELL INSIDE THE PT'S BLADDER. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478981 OLYMPUS HF-RESECTION ELECTRODE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D 13331P01L001

    Patients

    Seq Age Sex Outcome Treatment
    1 MODEL #WA22302D, LOT #13331P01L001,| MODEL #WA22302D, LOT #13331P01L001,| (2951238-2014-00316)| (2951238-2014-00315)