MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD HISTOCORE PELORIS 3 AUTOMATED TISSUE PROCESSOR; PROCESSOR, TISSUE, AUTOMATED

Model Number	HISTOCORE PELORIS 3 AUTOMATED TISSUE PROCESSOR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the customer contacted leica biosystems and reported ¿under process tissue both retorts and 2 runs affected tissue appears to be under process all biopsies, no error prompted, tissues appears hazy under scope.Tissue been fix prior to placing in the processor.No reagent change prior to run.Run to completion.¿ information provided by the leica field applications specialist ii (fas) detailed ¿the under processed tissue was reported as intermittent, not all specimens on the affected runs were processed poorly.The affected programs ran to completion with no instrument errors.Checked all reagent stations.There was no cross-contamination found in any of the stations.Fill levels for the reagent stations were appropriate except for station 3, which was over-filled.The reagent bottles were properly maintained, no noted excessive build-up in the bottles.¿ the fas ¿changed the reagent change threshold for xylene from 80% to 68%.Removed the 1200 cassette final threshold from the formalin station.Changed the ethanol final reagent threshold from 99% to 98% according to factory recommendations.¿ the fas also documented ¿the affected instrument is only used for biopsy tissues and one custom 4 hour protocol is used.Micromesh and fine pore biopsy cassettes are used exclusively on this processor, with occasional biopsy wraps included as well.¿ on 17 november 2025, the leica field applications specialist ii ¿ core histology ¿ east coast, usa received information that "the tissue status is currently not diagnosable on 1 affected case.The rest of the cases were able to be diagnosed.I have included demographic information on the adverse event form.The patient tissue that is not diagnosable has been recommended for re-biopsy; the procedure has not been performed yet." patient identifiers were provided for the affected patient.
Additional Manufacturer Narrative
The root cause for the ¿under process tissue¿ could not be unequivocally established from the information available.The information available suggests that non-standard fixation times during tissue processing may have contributed to the sub-optimal tissue processing reported by the customer.The information available indicates the affected patient tissue samples were re-processed by ¿direct reprocessing ¿ 1 case potential re-biopsy (on same processor)¿.This event led to one (1) patient being unable to be diagnosed.The following patient identifiers were provided by the customer ¿female¿ and ¿(b)(6) 1993¿.Manufacturer evaluation of the information available showed that the instrument functioned as designed, during the execution of the affected tissue processing runs.

• Brand Name: HISTOCORE PELORIS 3 AUTOMATED TISSUE PROCESSOR
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley; victoria 00000-0314 ; AS 0000003149 ; 61392117271
• MDR Report Key: 23764772
• Report Number: 8020030-2025-00076
• Device Sequence Number: 18577502
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)211013
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HISTOCORE PELORIS 3 AUTOMATED TISSUE PROCESSOR
• Device Catalogue Number: 45.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female