BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF RESECTION ELECTRODES

    MDR report key: 3002572 · Received February 15, 2013

    Report

    Report Number
    9610773-2013-00022
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 3, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWING 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 MFR (OEM) FOR FURTHER EVAL. PLEASE ALSO CROSS-REFERENCE 9610773-2013-00023.

    Additional Manufacturer Narrative · 1

    OCA UNDERTOOK A RETROSPECTIVE REVIEW OF ITS MDR FILES FOR THE PERIOD OF JANUARY 2005 TO APRIL 2015. BASED UPON THIS REVIEW, WE ARE SUBMITTING THIS SUPPLEMENTAL REPORT TO ACCOUNT FOR THE ADDITIONAL DEVICE AS REFERENCED IN THE ORIGINAL REPORT. (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
    67690 OLYMPUS HF RESECTION ELECTRODES ELECTRODE FAS OLYMPUS WINTER & IBE GMBH A22201C 12097P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1