BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISSUE PROCESSOR

    MDR report key: 25798 · Received July 26, 1995

    Report

    Report Number
    25798
    Event Type
    Other
    Date Received
    July 26, 1995
    Date of Event
    February 15, 1995
    Report Date
    March 10, 1995
    Manufacturer
    MILES INCORPORATED
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2/15 TISSUE WAS PLACED INTO THE TISSUE PROCESSOR. ON THE MORNING OF THE 16TH THE HISTOLOGY TECH ARRIVED IN THE LAB AT 5:45AM. TISSUE PROCESSOR SHOWED TISSUE STILL IN STATION 12, THE PARAFFIN WAS NOT PUMPED OUT. DIAGNOSIS ON (ERROR CODE). TECH CALLED CO & ASKED THEM TO OPEN THE BACK OF THE DEVICE TO CHECK THE JAR. THERE WAS PARAFFIN IN THE OVERFLOW JAR. IT WAS DISCOVERED THAT THE TISSUE HAD BEEN COMPROMISED WHEN THEY WERE READ BY THE PATHOLOGISTS. THERE WERE 4 CASES WHERE THE TISSUE COULD NOT BE READ BECAUSE OF THE ARTIFACT. TWO OF THE CASES THERE WAS SUFFICIENT TISSUE TO BE RESUBMITTED. TWO OF THE CASES WERE BIOPSY TISSUE. THE LIVER BIOPSY WAS REPEATED. THE OTHER TISSUE WAS PART OF SEVERAL SPECIMENS FROM 1 PT. IT WAS BIOPSY TISSUE FROM THE MASTOID AREA. THE REPAIRMAN CAME FROM CO ON 2/2. HE DISCOVERED A VACUUM PRESSURE LEAK IN A DIAPHRAGM. HE SAID THIS WAS A RARE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE PROCESSOR PROCESSOR OF TISSUE FROM SURGERY IEO MILES INCORPORATED VIP 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other