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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07 november 2025, the customer contacted leica biosystems with the following information: "over and under processed tissue occurred during daytime (b)(6) 2025.5 runs with 75 cases (more than one cassette / case).Across 4 peloris processors, user apparently ran tissues on incorrect programs.Tissue was either under processed, or very over processed.Over processed tissue rehydrated with softening agents some tissue recovered, some tissue not recovered, affected patients have been notified." on 02 december 2025, the leica field applications specialist (fas) investigating this event with the complainant provided the following additional information: at least one patient could not be diagnosed and the customer is unwilling to provide patient identifiers for the affected patient tissue sample(s) - the exact number of cases is unknown.The additional instruments involved in this event are documented in 3022446399-2025-00012, 3022446399-2025-00014 and 3022446399-2025-00015.

• 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 3149 ; AS 3149
• MDR Report Key: 23716085
• Report Number: 3022446399-2025-00013
• Device Sequence Number: 15698705
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)211123
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025
• Report Date (Section F): 12/04/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Other
• Date Report to Manufacturer: 12/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/04/2025