BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILESTONE

    MDR report key: 2306883 · Received October 12, 2011

    Report

    Report Number
    MW5022736
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 15, 2011
    Manufacturer
    MILESTONE SRL
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OUR LAB IS LOCATED WITHIN (B)(6) IN (B)(6). IT WAS SET-UP SIX MONTHS AGO BY (B)(6) AND ALL INSTRUMENT/MACHINES INSIDE THE LAB WERE INSTALLED BY THE SAME COMPANY BEFORE ANY HISTOLOGY STAFF WAS HIRED. ONE OF THE INSTRUMENTS INSIDE THE LAB IS A MICROWAVE PROCESSOR CAPABLE OF HOLDING FORTY-FIVE SPECIMENS/BIOPSIES. THE MACHINE WAS SUPPOSED TO BE PLUGGED INTO A SECURED OUTLET BY ITSELF HOWEVER, IN THIS CASE, THE MACHINE WAS PLUGGED INTO A MULTI-LINE CIRCUIT WITH OTHER INSTRUMENTS. ON (B)(6) 2011, THE MILESTONE PROCESSOR WAS LOADED WITH FORTY-FIVE SPECIMENS, CONSISTING OF BIOPSIES FROM EIGHTEEN PTS. THE MACHINE RAN FINE THROUGH THE FIRST TWO CYCLES HOWEVER DURING THE THIRD CYCLE THROUGH THE PARAFFIN, THE HISTOTECHNOLOGISTS SMELT SOMETHING BURNING. THEY NOTICED THAT THE SPECIMEN CASSETTES HAD MELTED INSIDE OF THE MACHINE AND DESTROYED ALL FORTY-FIVE OF THE SPECIMENS. MGMT WAS IMMEDIATELY NOTIFIED AND MILESTONE WAS CONTACTED. THE MACHINE WAS SHUT DOWN FOR THE REMAINDER OF THE DAY. THE DAY AFTER THE INCIDENT, THE MACHINE WAS INSPECTED BY SERVICE-MEN FROM MILESTONE AND IT WAS DETERMINED THAT THE PROBLEM HAD COME FROM THE FACT THAT THE ELECTRICAL WIRING WAS INCORRECTLY INSTALLED CAUSING THE MACHINE TO OVERHEAT. THE ELECTRICAL WIRING HAS SINCE BEEN PROPERLY INSTALLED IN THE CORRECT SECURED OUTLET AND THE MACHINE HAS BEEN RUNNING WITHOUT INCIDENT. THE ENDOSCOPY REPORTS FOR ALL FORTY-FIVE SPECIMENS BELONGING TO THE EIGHTEEN PTS SHOWED NO MAJOR INFLAMMATIONS, ULCERS, OR MASSES. (B)(6) OFFERED TO REPEAT THE PROCEDURES (UPPER AND/OR LOWER ENDOSCOPIES) WITH RE-BIOPSIES AT NO COST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILESTONE MICROWAVE PROCESSOR - KOS IEO MILESTONE SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other