BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6031602 · Received October 14, 2016

    Report

    Report Number
    1423337-2016-00011
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE INVESTIGATION BY THE LEICA MANUFACTURER, THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. NO USE ERROR(S) WAS IDENTIFIED IN THE INSTRUMENT LOGS AND NO INSTRUMENT FAILURE WAS DETECTED; THE DEVICE OPERATED WITHIN SPECIFICATION. SEE MANUFACTURER REPORT 8020030-2016-00068, 8020030-2016-00069, 8020030-2016-00070, 8020030-2016-00071, 8020030-2016-00072, 8020030-2016-00073 OR 8020030-2016-00074 FOR MORE INFORMATION.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT PROCESSED TISSUE CASSETTES SHOWED POOR MORPHOLOGY. ON 21 SEPTEMBER 2016, LEICA BIOSYSTEMS RECEIVED CONFIRMATION THAT SEVEN (7) CASES FROM THAT PROCESSING RUN HAD TO BE REBIOPSIED. PATIENT IDENTIFIER INFORMATION WAS PROVIDED FOR ALL CASES AND SEPARATE REPORTS HAVE ALSO BEEN SUBMITTED FOR ALL CASES. REPORT NUMBERS FOR ALL CASES ARE AS FOLLOWS: 1423337-2016-00010, 1423337-2016-00011, 1423337-2016-00012, 1423337-2016-00013, 1423337-2016-00014, 1423337-2016-00015 AND 1423337-2016-00016. PLEASE REFER TO THESE REPORTS FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681614 PELORIS RAPID TISSUE PROCESSOR PELORIS II IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other