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	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation of the information available determined that the root cause of the sub-optimal processing of patient tissue samples reported by the complainant was use of a protocol of inappropriate duration for the types and sizes of the patient tissue samples being processed.Specifically, the ¿12hr xylene standard¿ protocol is not appropriate for processing processing ¿gastric, derm, breast¿ tissue samples with sizes of ¿0.2 - 0.3 mm and 10mm x 0.4mm¿.Section 8.2.1 of the leica histocore peloris 3 premium tissue processing system user manual details the manufacturer recommended protocol duration for different maximum tissue thickness/dimensions and different example specimen types as follows: the 1 hour protocol is recommended for tissue of 1.5mm diameter/maximum thickness and the following example specimen types: endoscopies and needle biopsies of breast and prostate.The 2 hour protocol is recommended for tissue of <3mm diameter/maximum thickness and the following example specimen types: gi biopsies, renal; prostatic, hepatic and breast cores, punch biopsies of skin, small colonic polyps.The 4 hour protocol is recommended for tissue of 3mm diameter/maximum thickness and the following example specimen types: small specimens of non-dense tissues (kidney, liver, bowel etc), excisional an incisional skin biopsies, skin ellipses.The 6-8 hour protocol is recommended for tissue of 15x10x4mm maximum thickness and the following example specimen types: all routine cases up to maximum dimensions (excluding brain specimens).The 12 hour protocol is recommended for tissue of 20x10x5mm maximum thickness and the following example specimen types: all routine cases up to maximum dimensions.Very thick fatty specimens may require a longer protocol.Manufacturer evaluation of the service record for the instrument showed that a leica biosystems field service engineer (fse) was not dispatched to assess the operation and function of the instrument in association with this complaint.
Event or Problem Description
On 19 february 2024, the complainant contacted leica biosystems with the following details: ¿over processed biopsy tissue that were processed together with big specimens in a 12 hour cycle.Not all biopsy tissues were over processed.No error codes raised.The program ran to completion.The alcohol concentration reported 67,66,72,83,90,98,94,98.Followed by citraclear 99,99,79,94 concentration.¿ on 22 february 2024, the assigned field applications specialist ¿ (b)(4) visited the complainant¿s site to assess the operation and function of the instrument and documented the following: ¿three techs and supervisor confirmed that small gastric biopsies are being placed on 12 hour run with fatty tissue and breast specimens.Instrument clean, retort and liquid level sensors clean, no evidence of salt.No evidence of adipose residue in bottles.Eosin on board on bottles 5-10, bottles 3-4 are designated 70% ethanols and do not contain eosin.Mild ink residue in bottle 4.Custom protocols, standard thresholds.Customer only uses one retort.All ethanols tested within +/- 5 points of software.Bottles and retorts don¿t show evidence of adipose residue or salt.No evidence of adverse event codes.¿ the fas ¿programmed 4hr protocol based on settings in quick tips guide, validated in system, customer will test with non-clinical tissue and use moving forward for small biopsies.¿.The fas documented the affected patient tissue samples were derived from one (1) ¿12 hour¿ protocol comprising ¿96 total ; approx.30 blocks on run affected, only small biopsies¿ cassettes, which started in retort a with a start/end time & date of ¿(b)(6) 2024 @ 10:04am / (b)(6) 2024 @ 3:59am¿.The tissue type(s) and size(s) were documented as ¿gastric, derm, breast¿ and ¿0.2 - 0.3 mm and 10mm x 0.4mm¿, respectively.The tissue artefact was described as ¿over processed biopsy tissues ; crunchy and brittle at embedding and microtomy¿ and the affected tissue samples were not reprocessed.On 24 february 2024, leica biosystems melbourne received confirmation from the assigned leica field applications specialist ¿ core histology, mid-atlantic that all patient cases were diagnosable; and no re-biopsy was 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 waverley; victoria 00000 0314; AS 0000003149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149; AS
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley, vic 3149; AS ; 92117271
• MDR Report Key: 18937496
• Report Number: 8020030-2024-00013
• Device Sequence Number: 6971550
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)220628
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Distributor Facility Aware Date: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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