BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA ASP300S

    MDR report key: 4996470 · Received August 10, 2015

    Report

    Report Number
    8010478-2015-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 6, 2015
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY THE MANUFACTURER. LEICA BIOSYSTEMS IS ISSUING THE FIELD SAFETY NOTICE(FSN) TO INFORM THE CUSTOMER ABOUT A FIELD SAFETY CORRECTIVE ACTION (FSCA) THAT WE ARE INITIATING, TO ADDRESS AN ISSUE WE HAVE EXPERIENCED WITH OUR TISSUE PROCESSOR, (B)(4).

    Description of Event or Problem · 1

    THE AFFECTED DEVICE HAS AN INCORRECT INTERNAL WIRING TO THE REMOTE ALARM PLUG, WHICH CAN CAUSE THE REMOTE ALARM TO NOT FUNCTION CORRECTLY IN THE CASE OF AN INSTRUMENT FAILURE. IN CASE A CUSTOMER HAVE AN INSTRUMENT FAILURE DURING PROCESSING AND THE CUSTOMER CURRENTLY RELY ON THE REMOTE ALARM, THE MISSING ALARM SIGNAL COULD LEAD TO SUBOPTIMAL QUALITY PROCESSING. IN SOME CASES, A RE-BIOPSY OF THE PATIENT COULD BE NECESSARY IN ORDER TO OBTAIN ANOTHER VIABLE TISSUE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522902 LEICA ASP300S AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 14047643515

    Patients

    Seq Age Sex Outcome Treatment
    1