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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this complaint found the instrument functioned as designed during the execution of ¿[protocol name]¿ protocol comprising 195 cassettes which started in retort a at 0:45 on 21 june 2024 and completed successfully at 03:59 on 21 june 2024, from which sub-optimal tissue processing was reported by the complainant.The root cause for the sub-optimal processing of patient tissue samples reported by the complainant from the affected run was a use error, which occurred at 23:19 on 20 june 2024.Specifically, a user failed to complete manual replacement of the reagent in bottle 12 (clear-rite) in accordance with the manufacturer instructions detailed in section 5.4.4 of the leica histocore peloris 3 user manual, which contains the following specific warning: ¿always change reagents when prompted.Always update station details correctly ¿ never update the details without replacing the reagent.Failure to follow these directives can lead to tissue damage or loss.¿ the information available indicates that the instrument returned to normal functionality following ¿all bottles, retorts, wax lines and wax chambers, flushed with ethanol and clearite [sic]¿ by the assigned fse.
Event or Problem Description
On 21 june 2024, the complainant contacted leica biosystems with the following details: ¿under process tissue no error code/ ran to completion ret a.Underprocess [sic] tissue, reagent changed prior to running and user change one of clearite [sic] bottle 12 with clarifier.Ran on retort a to completion, no error prompted.User discover when retrieving the tissue with strong scent of clarifier and 195 biopsy tissue affected.¿ on 21 june 2024, the leica field applications specialist ¿ core histology, mid-atlantic visited the customer site and documented the following: ¿¿staff member filled clearite [sic] bottle with clarifier¿per customer, 12 hour cassettes smell like vinegar (acid) after processing, likely due to wax contamination with clarifer; all wax chambers have strong acid scent.Ethanol concentrations on several bottles read higher with hydrometer than in software.¿ on 22 june 2024, the field applications specialist ii provided the following additional information regarding the circumstances of the event: ¿the overnight tech replaced bottle 12 with clarifier instead of clear-rite¿retort a used bottle 12 with the incorrect reagent¿customer reprocessed blocks from retort a manually and added blocks to [instrument name].[instrument name] was not changed last night by the overnight tech.Xylene and wax reagents should be replaced on the instrument.¿ on 25 june 2024, the assigned leica field service technician (fse) visited the customer site and documented the following: ¿decommissioned instrument and reinstalled.All bottles, retorts, wax lines and wax chambers, flushed with ethanol and clearite [sic].Per peloris decommissioning procedure.Instrument refilled.Minimum verification ran and fss ran a dummy run.Customer to run test tissue before use.¿ the fas documented affected patient tissue was derived from one (1) ¿factory 2hr xylene¿ protocol comprising 195 cassettes executed in retort a, which started at ¿1 am¿ on 21 june 2024 and completed at ¿3 am¿ on 21 june 2024.The type(s) and size(s) of the affected patient tissue samples were documented as ¿gastrointestinal, skin shaves and nails¿ and ¿2 mm or less¿, respectively.The tissue artefact was described as ¿under processed tissue¿ and the affected tissue samples were reprocessed by ¿manual re-process tissue on the benchtop¿.On 25 june 2024, a leica global technical support manager ¿ applications documented the following information regarding clarifier: ¿the sds states the reagent is 3-6% acetic acid.¿ on 03 july 2024, leica biosystems melbourne received information from the local field applications specialist ¿ core histology that all patient cases were diagnosable.Re-biopsy of a patient(s) had not been either recommended or performed.No adverse consequence(s) to a patient(s) has been reported to the manufacturer.

• 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 waverly; 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, vic; AS 0000003149 ; 92117271
• MDR Report Key: 19768051
• Report Number: 8020030-2024-00024
• Device Sequence Number: 20960660
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)190923
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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
• Patient Sex: Unknown