BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS TISSUE PROCESSOR

    MDR report key: 2220632 · Received July 27, 2011

    Report

    Report Number
    8020030-2011-00039
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE INVESTIGATION OF THIS COMPLAINT. ON-SITE ASSESSMENT OF THE OPERATION AND FUNCTION OF THE INSTRUMENT WAS CONDUCTED BY A LEICA FIELD SVC ENGINEER (FSE) ON (B)(4) 2011. THE FSE CONDUCTED A NUMBER OF PERFORMANCE TESTS WHICH COMPLETED SATISFACTORILY. DURING THE PROCESS OF FLUSHING THE WAX BATHS AND WAX LINES, THE FSE FOUND A SMALL PIECE OF CARDBOARD IN WAX BATH 3. THE WAX VALVES WERE REBUILT, AND THE RESULT OF THE INSTRUMENT PERFORMANCE TEST SUBSEQUENTLY CONDUCTED WAS SATISFACTORY. NO ERROR CODES WERE RECORDED IN THE INSTRUMENT SOFTWARE DURING EXECUTION OF THE TWO PROTOCOLS FROM WHICH SUB-OPTIMAL PROCESSING WAS IDENTIFIED. IMPORTANTLY, THE "1337" ERROR CODE, WHICH INDICATES THAT A SUDDEN RAPID AND UNEXPECTED DROP IN THE RETORT WAX LINE TEMP LIKELY DUE TO A LEAKING RETORT WAX VALVE ALLOWING COLD REAGENT INTO THE LINE CAUSING A FORMALIN CONTAMINATION OF THE WAX WAS NOT RECORDED. AS A CONSEQUENCE, IT APPEARS THAT THE FOREIGN MATERIAL FOUND BY THE FSE HAD NOT BECOME LODGED IN THE WAX VALVE, AND DID NOT CAUSE OR CONTRIBUTE TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING RESULTING IN BOTH UNDER AND OVER-PROCESSED TISSUE WHICH WAS IDENTIFIED FROM TWO (2) PROTOCOLS COMMENCING AND COMPLETING ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). THE COMPLAINANT ALSO REPORTED THE PRESENCE OF DROPLETS OF FORMALIN IN WAX BATH 4. ON (B)(6) 2011, THE COMPLAINANT ADVISED LEICA MICROSYSTEMS THAT TWENTY (20) SAMPLES EXHIBITING SUB-OPTIMAL TISSUE PROCESSING COULD NOT BE RECOVERED, AND THAT PT RE-BIOPSY WILL BE REQUIRED. LEICA MICROSYSTEMS HAS NOT BEEN ADVISED WHETHER PT RE-BIOPSY HAS BEEN PERFORMED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1