BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA TP1020

    MDR report key: 2070278 · Received April 19, 2011

    Report

    Report Number
    8010478-2011-00004
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    September 29, 2010
    Report Date
    March 23, 2011
    Manufacturer
    LEICA BIOSYSTEMS GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THE DAMAGED TISSUES, THE CUSTOMER COULD NOT EVALUATE THEM ALL AND SOME PATIENTS REQUIRED REBIOPSY. THE UNIT WAS EVALUATED BY A LEICA SERVICE SUPPORT PRODUCT SPECIALIST. THE ANALYSIS INDICATED THAT THE CAUSE FOR THE DAMAGED TISSUE WAS DUE TO UNSATISFACTORY ADJUSTMENT OF THE GRIPPER. AS A RESULT, THE PROCESSING STOPPED BECAUSE THE BASKET COULD NOT BE LOWERED PROPERLY INTO THE REAGENT STATION AND THUS REMAINED HANGING ON THE EDGE. BECAUSE THE CUSTOMER DID NOT RESPOND TO THE UNIT'S ALARM, THE TISSUE REMAINED IN THE AIR AND DAMAGED THE TISSUES. AFTER THE GRIPPER HAS BEEN ADJUSTED, A NEW TEST RUN WAS CONDUCTED WHICH CONFIRMED THE PROPER FUNCTIONING OF THE UNIT.

    Description of Event or Problem · 1

    THE INSTRUMENT STOPPED DURING AN OVERNIGHT PROCESSING. CONSEQUENTLY, THE TISSUE WAS DAMAGED BECAUSE THE PROCESS JAMMED ON POSITION 6. THE ALARM WAS NOT HEARD BY THE HOSPITAL SINCE IT WAS AN OVERNIGHT PROCESSING AND, THEREFORE, THE TISSUES WERE NOT DIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA TP1020 TISSUE PROCESSOR IEO LEICA BIOSYSTEMS GMBH TP1020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other