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 27 september 2024, the assigned leica field applications specialist ii ¿ core histology, northwest (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 so sought medical attention.An ophthalmologist examined the affected staff member and diagnosed them with chemical conjunctivitis due to exposure to formalin fumes.The affected staff member missed approximately five (5) hours of work whilst receiving medical attention.
Additional Manufacturer Narrative
The information provided by the customer details 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.The affected staff member sought medical attention due to the circumstances of the event.Based on the information available it is considered that the root cause for the reported ¿formalin fume exposure " was a use error.Specifically, a user failed to follow the instructions detailed in section 3.5 of the leica biosystems histocore peloris 3 user manual, which contains the following instruction: ¿when processing stops, the peloris 3 goes through the same routines it does at the end of a normal protocol run.It prompts you to drain the retort (if full), remove cassettes, and run a cleaning protocol.¿ the failure to clean the retort after the removal of formalin-soaked patient tissue samples resulted in residual formalin to remain in the retort.This user action would have resulted in the accumulation of formalin fumes in the retort which were expelled once the retort was opened.Section 3.5 of the leica biosystems histocore peloris 3 user manual contains the following specific warning: ¿take care if opening a retort or wax chamber after pausing the instrument.Retorts may contain very hot fluid, hazardous reagents and vapors.Read any warning messages¿for example, the retort is above safe access temperature¿and take appropriate precautions before continuing.¿.Review of the service history for the histocore peloris 3 automated tissue processor serial number (b)(6) showed that leica biosystems has not received any previous report(s) of a user injury sustained due to formalin exposure from this customer site.Review of the service history for the histocore peloris 3 automated tissue processor serial number (b)(6) also did not identify any issue(s) that would have either caused or contributed to the circumstances reported by the complainant.

• 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; AS 0000003149 ; 92117271
• MDR Report Key: 20519378
• Report Number: 8020030-2024-00034
• Device Sequence Number: 7793646
• 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: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: Required Intervention
• Patient Sex: Unknown