BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS II AUTOMATED TISSUE PROCESSOR

    MDR report key: 22110678 · Received May 29, 2025

    Report

    Report Number
    8020030-2025-00055
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 30, 2025
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    UDI-DI
    09349458000233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THE ¿3HR XYLENE¿ PROTOCOL COMPRISING 174 CASSETTES EXECUTED IN RETORT B, WHICH STARTED AT 08:44 ON (B)(6) 2025 AND COMPLETED SUCCESSFULLY AT 11:54 ON (B)(6) 2025, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE CUSTOMER. INFORMATION RECEIVED FROM THE ASSIGNED LEICA FIELD APPLICATION SPECIALIST ¿ CORE HISTOLOGY TEXAS (FAS) DETAILED ¿3 BASKETS WITH 174 PROCESSED, ONLY TWO BASKETS REMOVED. THE 3RD BASKET HAD 20 CASSETTES AND WAS LEFT IN RETORT. A CLEANING CYCLE WAS COMPLETE WITH THE 20 CASSETTES.¿ THIS INFORMATION INDICATES THAT THE USER FAILED TO FOLLOW THE MANUFACTURER INSTRUCTIONS DETAILED IN SECTION 3.2 OF THE LEICA PELORIS II USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARNING: ¿DO NOT USE CLEANING PROTOCOLS FOR REPROCESSING AS THE DRY STEP WILL DAMAGE THE TISSUE.¿ ACCORDINGLY, EXPOSURE OF THE PATIENT TISSUE SAMPLES TO THE RETORT CLEANING PROTOCOLS WOULD HAVE ADVERSELY IMPACTED THE PATIENT TISSUE SAMPLES. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT ALL PATIENT CASES INVOLVED IN THIS EVENT WERE DIAGNOSABLE, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. NO ADVERSE IMPACT ON EITHER THE QUALITY OF PROCESSING OF PATIENT TISSUE SAMPLES OR TO ANY PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER IN ASSOCIATION WITH THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: ¿THREE BASKETS PROCESSED AND 1 WAS LEFT INSIDE RETORT A AND CLEANING CYCLE WAS RUN AND LAST BASKET HAD 20 BLOCKS. THEY REPROCESS THE 20 CASSETTES IN DIFFERENT PELORIS. RESULT PENDING ON THE REPROCESS TISSUES.¿ ON (B)(6) 2025, THE ASSIGNED LEICA FIELD APPLICATION SPECIALIST ¿ CORE HISTOLOGY TEXAS (FAS) VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING: ¿- 174 CASSETTES WERE PROCESSED WITHIN 3 BASKETS, TWO BASKETS WERE REMOVED FOR EMBEDDING, AND THE LAST BASKET WITH 20 CASSETTES STAYED IN RETORT - CUSTOMER NOTICED TISSUE IN RETORT AND NO WAX INFILTRATED ON TISSUES - CUSTOMER LOADED THE 20 CASSETTES ON ANOTHER PELORIS 3 - 20 CASSETTES LOADED ON 3 HR XYLENE STARTING WITH TWO CHANGES OF ABSOLUTE ETHANOL TO WAX. - CUSTOMER NOTED TISSUES CUT FINE - H&E'S PENDING PATHOLOGIST REVIEW¿. THE FAS DOCUMENTED THE AFFECTED PATIENT TISSUE SAMPLES WERE DERIVED FROM ONE (1) ¿3HR XYLENE¿ PROTOCOL COMPRISING ¿20 OUT OF 174¿ CASSETTES WHICH STARTED IN RETORT B AT 08:44 ON (B)(6) 2025 AND COMPLETED AT 11:54. THE AFFECTED PATIENT TISSUE TYPE(S) AND SIZE(S) WERE DESCRIBED AS ¿GYN BIOPSIES, EMB, CURRETTINGS, CERVIX BIOPSIES¿ AND ¿UNKNOWN¿, RESPECTIVELY. THE TISSUE ARTEFACT WAS DESCRIBED AS ¿UNKNOWN¿ AND THE AFFECTED PATIENT TISSUE SAMPLES WERE REPROCESSED BY A ¿USER-DEFINED¿ METHOD. THE FAS ALSO DOCUMENTED ¿3 BASKETS WITH 174 PROCESSED, ONLY TWO BASKETS REMOVED. THE 3RD BASKET HAD 20 CASSETTES AND WAS LEFT IN RETORT. A CLEANING CYCLE WAS COMPLETE WITH THE 20 CASSETTES. TISSUE WAS DISCOVERED AND PLACED ON A DIFFERENT PROCESSOR TO COMPLETE.¿ ON (B)(6) 2025, LEICA BIOSYSTEMS MELBOURNE RECEIVED INFORMATION THAT ALL PATIENT TISSUES WERE DIAGNOSED. NO RE-BIOPSY WAS RECOMMENDED OR PERFORMED. NO ADVERSE CONSEQUENCE(S) FOR ANY PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26044 PELORIS II AUTOMATED TISSUE PROCESSOR PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II AUTOMATED TISSUE PROCESSOR 09349458000233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown