BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS II AUTOMATED TISSUE PROCESSOR

    MDR report key: 22025012 · Received May 15, 2025

    Report

    Report Number
    8020030-2025-00052
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 11, 2025
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    UDI-DI
    09349458000028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS COMPLAINT FOUND THE INSTRUMENT FUNCTIONED AS DESIGNED DURING THE EXECUTION OF BOTH THE ¿MPS FAT RUN 10HR¿ PROTOCOL COMPRISING 58 CASSETTES WHICH STARTED IN RETORT B AT 21:17 ON (B)(6) 2025 AND COMPLETED SUCCESSFULLY AT 07:17 ON (B)(6) 2025 AND THE ¿MPS 1HR¿ PROTOCOL COMPRISING 150 CASSETTES WHICH STARTED IN RETORT A AT 10:29 ON (B)(6) 2025 AND WAS ABANDONED BY A USER AT 11:04 ON (B)(6) 2025, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE CUSTOMER. MANUFACTURER EVALUATION OF THE INSTRUMENT LOGS SHOWS NO EVIDENCE OF A QUICK CLEAN PROTOCOL INCLUDING THE DRY STEP BEING USED BY THE CUSTOMER AFTER THE AFFECTED TISSUE PROCESSING RUNS. THEREFORE, LEICA BIOSYSTEMS FINDS IT UNLIKELY THE ROOT CAUSE OF THE ¿TISSUE COMPROMISED - FAT RUNS DESTROYED¿¿ REPORTED BY THE CUSTOMER WAS THE USE OF A QUICK CLEAN CYCLE INCLUDING THE DRY STEP. THE ROOT CAUSE FOR THE ¿TISSUE COMPROMISED - FAT RUNS DESTROYED¿¿ REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT INFORMATION RECEIVED BY THE MANUFACTURER FROM THE CUSTOMER OUTLINING THAT THERE WAS NO ADVERSE EVENT AND AFTER ADDITIONAL TESTING, THE CUSTOMER HAS DETERMINED THERE WAS NO ADVERSE IMPACT TO ANY PATIENT AFFECTED BY THIS EVENT. SECTION B5 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL AND CORRECTED INFORMATION.

    Description of Event or Problem · 0

    ON 15 APRIL 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT WITH THE FOLLOWING DETAILS: ¿TISSUE COMPROMISED - FAT RUNS DESTROYED ¿ TISSUE COMPLETELY COOKED ¿ TISSUE NOT DIAGNOSTIC ¿ MULTIPLE PATIENTS COMPROMISED. THOUGHT TISSUE MAY HAVE GONE THROUGH A CLEANING CYCLE ¿ HOWEVER WE COMPLETELY CHANGED THE SOLUTIONS AND HAVE JUST HAD A REPEAT¿. THE LEICA SNR. ADV. APPLICATIONS SPECIALIST ANZ (FAS) DOCUMENTED THE AFFECTED PATIENT TISSUE SAMPLES WERE DERIVED FROM THE FOLLOWING PROTOCOLS: ¿MPS FAT RUN 10HR 58 CASSETTES / MPS 1HR 150 CASSETTES¿ EXECUTED IN BOTH RETORT A AND RETORT B WITH A START/END TIME & DATE RECORDED AS ¿(B)(6) 2025 21:17:25 -(B)(6) 2025 07:18:59 /(B)(6) 2025 10:29:40 - (B)(6) 2025 11:05:22¿. THE AFFECTED TISSUE ARTEFACT WAS DESCRIBED AS ¿TISSUE HARD, BRITTLE, WHITE IN PLACES, LOOKS LIKE GLASS/MARBLE IN SOME PLACES. SLIDES HAVE NO MEMBRANE DETAIL, SOME AREAS LOOK LIGHTER LIKE A WHITER OR RUBBED OUT APPEARANCE, SOME TISSUE CHUNKING OUT DURING CUTTING.¿ THE AFFECTED PATIENT TISSUE SAMPLES WERE RE-PROCESSED BY ¿CUSTOMER USED QUICK CLEAN PGRM. REPORTED STOPPING IT BEFORE HEATING STEP.¿ THE FAS ALSO OBSERVED AN EXCESS OF WAX AROUND THE WAX BATH SEALS AND BEHIND THE INSTRUMENT. THE 85% REAGENTS WERE DISPOSED OF AND REMADE AS THE HYDROMETER READINGS WERE VERY OFF. ON (B)(6) 2025, LEICA BIOSYSTEMS MELBOURNE RECEIVED INFORMATION FROM THE LEICA SNR. ADV. APPLICATIONS SPECIALIST ANZ THAT ¿2 CASES CONFIRMED UNDIAGNOSABLE SO FAR (JUST GOT OFF THE PHONE WITH [(B)(6)]). THE REST STILL UNDETERMINED.¿ AS AT (B)(6) 2025, LEICA BIOSYSTEMS MELBOURNE HAS NOT RECEIVED INFORMATION REGARDING FINAL PATIENT OUTCOME OR PATIENT IDENTIFIERS FOR THE ¿2 CASES CONFIRMED UNDIAGNOSABLE¿¿

    Description of Event or Problem · 0

    ON 18 JUNE 2025, LEICA BIOSYSTEMS MELBOURNE RECEIVED UPDATED INFORMATION FROM THE LEICA SNR. ADV. APPLICATIONS SPECIALIST ANZ THAT ¿TISSUES WERE INITIALLY REPROCESSES [SIC] USING RADID [SIC] REPROCESS. THEN TAGGARTS METHOD WAS USED AS DESCRIBED IN THE IFU, BEFORE AGAIN PROCESSING. THE CUSTOMER WAS ABLE TO DIAGNOSE BY USING IHC PLATFORM AND ONLY USING THE COUNTERSTAIN. THE CUSTOMER DID NOT REPORT ANY TISSUE FULLY LOST/DESTROYED 2 WEEKS AFTER THE INCIDENT. NO RE-BIOPSY REQUESTED.¿ NO ADVERSE NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346923 PELORIS II AUTOMATED TISSUE PROCESSOR PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II AUTOMATED TISSUE PROCESSOR 09349458000028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other