BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF RESECTION ELECTRODE

    MDR report key: 2240885 · Received August 5, 2011

    Report

    Report Number
    9610773-2011-00019
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 7, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    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 THE REFERENCED DEVICE "SNAPPED" DURING A HYSTEROSCOPY WITH BIOPSY PROCEDURE. THE USERS REPORTEDLY MADE ONE PASS, PULLED THE ELECTRODE OUT AND DETECTED A GAP IN THE ELECTRODE LOOP WITH TWO SMALL BALLS AT EACH SIDE OF THE REMAINING LOOP. THE USER FACILITY REPORTEDLY COULD NOT DETERMINE WHETHER ANY DEVICE FRAGMENTS WERE LEFT INSIDE THE PT'S BODY CAVITY AS NO X-RAY WAS TAKEN. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A DIFFERENT BUT SIMILAR ELECTRODE. THERE WAS NO PT HARM PER THE USER FACILITY. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THAT THE LOOP WAS BROKEN AND ENDS OF THE REMAINING PORTIONS OF THE LOOP APPEARED TO HAVE MELTED. THE ELECTRODE HAS BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVALUATION. IF ADD'L SIGNIFICANT INFO IS RECEIVED, THIS REPORT SHALL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A VOLUNTARY REPORT FROM THE MEDWATCH REPORTING PROGRAM, WHICH REPORTED A MALFUNCTION HAD OCCURRED. THERE WAS NO REPORT OF ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HF RESECTION ELECTRODE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D 10YW

    Patients

    Seq Age Sex Outcome Treatment
    1