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	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Leica biosystems received a complaint of overprocessed tissue.The leica biosystems field applications specialist (fas), investigating this event with the complainant, provided the following information, "on (b)(6) 2024, i was told by the supervisor that there was at least one case that was more than likely not going to be able to be diagnosed.It was confirmed on (b)(6) 2024, that two cases could not be diagnosed for sure." the fas also documented that re-biopsy has been recommended.Information regarding both the patient identifiers and the associated patient impact/outcome has not been provided to leica biosystems.Multiple attempts were made to obtain this information from the complainant; however, as of (b)(6) 2024, leica biosystems has not received information as to either the patient identifiers of the patient tissue samples involved in this event or the patient impact/outcome.

• 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: 20584855
• Report Number: 3022446399-2024-00007
• Device Sequence Number: 12892079
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)240123
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/31/2024
• Report Date (Section F): 10/31/2024

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: 10/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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: 10/31/2024