BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 472153 · Received July 11, 2003

    Report

    Report Number
    9610773-2003-00018
    Event Type
    Malfunction
    Date Received
    July 11, 2003
    Date of Event
    March 17, 2003
    Report Date
    June 12, 2003
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED SOLUTION FROM THE HYSTEROSCOPE MADE CONTACT WITH THE ELECTRODE CORD WHICH CAUSED A LARGE SPARK AND RUPTURE OF THE ELECTRODE. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ELECTRODE CORD FFZ OLYMPUS WINTER & IBE GMBH UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN