BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3842689 · Received May 14, 2014

    Report

    Report Number
    8020030-2014-00017
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, LEICA BIOSYSTEMS REC'D A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF 111 SPECIMENS FROM A 12 HOUR PROTOCOL, USING PELORIS 11 TISSUE PROCESSOR. THE COMPLAINANT DESCRIBED THE AFFECTED TISSUE SAMPLES AS "RUBBERY"; AND ADVISED THAT RE-PROCESSING WAS BEING PERFORMED ON AN ALTERNATIVE PELORIS TISSUE PROCESSOR LOCATED IN THE LABORATORY. ON (B)(6) 2014, LEICA BIOSYSTEMS REC'D INFO FROM THE LABORATORY CONFIRMING THAT TISSUE FROM THREE (3) PATIENTS WAS NOT DIAGNOSABLE. ON (B)(6) 2014, LEICA BIOSYSTEMS REC'D FURTHER INFO FROM THE LABORATORY INDICATING THAT RE-BIOPSY OF ONE (1) OF THE THREE (3) PATIENTS FROM WHOM TISSUE WAS NOT DIAGNOSABLE. ON (B)(6) 2014, LEICA BIOSYSTEMS REC'D THE AGE AND GENDER FOR THE PATIENT FOR WHOM A RE-BIOPSY HAS BEEN PERFORMED. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287854 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention