BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE

    MDR report key: 1701059 · Received May 24, 2010

    Report

    Report Number
    9610773-2010-00012
    Event Type
    Other
    Date Received
    May 24, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 26, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USERS REPORT, AS THE TIP OF THE ELECTRODE WAS FOUND DAMAGED AND DETACHED. THERE WAS EVIDENCE OF THERMAL DAMAGE NOTED ON BOTH ENDS OF THE LOOP PIECES, AND BIOMATERIALS ON THE SURFACE OF THE LOOP. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. NO OTHER EQUIPMENT USED DURING THE PROCEDURE WAS RETURNED FOR EVALUATION, AS THERE WERE NO ALLEGATIONS OF MALFUNCTION ASSOCIATED WITH THE OTHER ITEMS. THE DEVICE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER EVALUATION. IF SIGNIFICANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE (TURP) THE DISTAL TIP OF THE ELECTRODE LOOP BROKE OFF INSIDE THE PT AFTER TWENTY MINUTES OF USE. THE BROKEN PORTION OF THE LOOP WAS RETRIEVED WITH AN UNK DEVICE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT, BUT SIMILAR ELECTRODE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE LOOP ELECTRODE JOS OLYMPUS WINTER & IBE GMBH WA22302D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 WORKING ELEMENT WA22367A| TELESCOPE MODEL A2201A| OUTER SHEATH A22026A| INNER SHEATH A22040A| HF CABLE WA00013A| OLYMPUS UES-40 SERIAL NUMBER (B)(4)