BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6077207 · Received November 3, 2016

    Report

    Report Number
    1423337-2016-00020
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT TISSUE SAMPLES EXHIBITED SUB-OPTIMAL PROCESSING AND MAY BE UNDIAGNOSABLE. ON 06 OCTOBER 2016, LEICA BIOSYSTEMS RECEIVED CONFIRMATION THAT SEVEN (7) CASES WERE UNDIAGNOSABLE AND WOULD REQUIRE REBIOPSY. PATIENT IDENTIFIER INFORMATION WAS PROVIDED FOR ALL CASES AND SEPARATE REPORTS HAVE ALSO BEEN SUBMITTED FOR ALL CASES. (B)(6). REPORT NUMBERS FOR ALL CASES ARE AS FOLLOWS: 1423337-2016-00017, 1423337-2016-00018, 1423337-2016-00019, 1423337-2016-00020, 1423337-2016-00021, 1423337-2016-00022 AND 1423337-2016-00023. PLEASE REFER TO THESE REPORTS FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727503 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other