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	Conjunctivitis (1784)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the customer contacted leica biosystems with the following information: "customer complains of formalin fume exposure, and has had medical attention." on (b)(6) 2024, the assigned leica biosystems field applications specialist (fas) visited the customer and documented that a user initially loaded patient tissue samples into retort b and started a tissue processing protocol.The user then abandoned the tissue processing protocol, drained the reagent from the retort, and moved the patient tissue samples to retort a.The user closed the lid to retort b, which contained residual formalin, and did not execute a cleaning protocol.The affected staff member opened retort b and was exposed to an abundance of formalin fumes that had accumulated in the retort.Approximately twenty (20) minutes after exposure, the affected staff member started to experience cloudiness in her right eye and sought medical attention.An ophthalmologist examined the affected staff member and diagnosed her with chemical conjunctivitis due to exposure to formalin fumes.The affected staff member missed approximately five (5) hours of work whilst receiving medical attention.

• 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: 20528343
• Report Number: 3022446399-2024-00006
• Device Sequence Number: 7984128
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)211116
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/24/2024
• Report Date (Section F): 10/24/2024

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: 09/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• 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: Female
• Date Report Sent to FDA: 10/24/2024