BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF RESECTION ELECTRODES

    MDR report key: 3002571 · Received February 15, 2013

    Report

    Report Number
    9610773-2013-00023
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT WITH NO FURTHER DETAILS PROVIDED. THREE ELECTRODE LOOPS WERE RETURNED TO OLYMPUS FOR EVAL. TWO OF THE ELECTRODES HAD A LOT NUMBER OF 12223P03L001 AND THE EVAL FOUND BOTH OF THE LOOP WIRES HAD ONE END DETACHED AT THE YELLOW FILTER SECTION. THE THIRD ELECTRODE HAD A LOT NUMBER OF 12097P03L001 AND THE EVAL NOTED THAT THE LOOP WIRE WAS BROKEN OFF IN THE CENTER. THE DEVICES WERE FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER EVAL. (B)(4).

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THREE OF THE ELECTRODE LOOP WIRES WERE BREAKING DURING A THERAPEUTIC TRANSURETHRAL RESECTION BLADDER TUMOR (TURBT) PROCEDURE. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A DIFFERENT BUT SIMILAR DEVICE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66573 OLYMPUS HF RESECTION ELECTRODES ELECTRODE FAS OLYMPUS WINTER & IBE GMBH A22201C 12223P03L001 (2X)

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS UES-40 WITH UNK, SERIAL NUMBER