BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION ELECTRODE

    MDR report key: 1833275 · Received September 7, 2010

    Report

    Report Number
    9610773-2010-00029
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 10, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT IS EN ROUTE TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL FOLLOW FOLLOWING COMPLETION OF THE EVAL. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. OLYMPUS (B)(4) IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC RESECTION OF PROSTATE (TURP) PROCEDURE, THE LOOP DISINTEGRATED. FOLLOWING THE PROCEDURE, AN X-RAY WAS PERFORMED ON THE PT AND THERE WAS NO INDICATION OF ANY DEVICE FRAGMENTS BEING LEFT INSIDE THE PT. THERE WAS 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4): LOT NUMBERS UNKNOWN| OLYMPUS (B)(4) WORKING ELEMENT AND| OLYMPUS UES-40 ELECTROSURGICAL UNIT:| SERIAL NUMBER UNKNOWN| SERIAL NUMBER UNKNOWN| OLYMPUS UES-40 ELECTROSURGICAL UNIT:| (B)(4): LOT NUMBERS UNKNOWN| OLYMPUS (B)(4) WORKING ELEMENT AND