BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION ELECTRODE

    MDR report key: 1887904 · Received October 29, 2010

    Report

    Report Number
    9610773-2010-00039
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    July 9, 2010
    Report Date
    October 5, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE PROCEDURE PERFORMED WAS A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE (TURP). THE USER FACILITY STAFF REPORTED THAT THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED MODEL OF A NEW LOOP ELECTRODE. IN ADDITION, THE USER FACILITY HAVE REPORTED THAT NO DEVICE FRAGMENT HAVE BEEN IDENTIFIED INSIDE THE PT. THE DEVICE REFERENCED IN THIS REPORT WAS REPORT TO BE IN TRANSIT TO BE RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. FOLLOWING COMPLETION OF THE EVAL, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION. GYRUS ACMI REGISTRATION NUMBERS (B)(4). EXEMPTION NUMBER (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE AN ELECTRODE LOOP BROKE INSIDE THE PT DURING AN UNSPECIFIED TYPE OF PROCEDURE. THE USER FACILITY REPORTED THAT IT WAS UNCLEAR IF ALL PARTS OF THE DEVICE HAVE BEEN RETRIEVED. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION ELECTRODE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D 09278P00L001

    Patients

    Seq Age Sex Outcome Treatment
    1 FOOTSWITCH MAJ-1258| HF CABLE WA00013A| INTER SHEATH A22040A/T | OLYMPUS UES-40 WITH SN#(B)(6)| TELESCOPE A22001A| WERE USED DURING THE PROCEDURE.| WORKING ELEMENT WA22366A| HF CABLE WA00013A| WERE USED DURING THE PROCEDURE.| OLYMPUS UES-40 WITH SN#(B)(4)| FOOTSWITCH MAJ-1258| WORKING ELEMENT WA22366A| INTER SHEATH A22040A/T| TELESCOPE A22001A