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	01/24/2024
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 ¿[protocol name]" and ¿[protocol name]¿ protocols are not appropriate for processing ¿colon biopsy samples and small lymph nodes¿ with a size of ¿1.5mm¿ 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 was not dispatched to assess the operation and function of the instrument in association with this complaint.
Event or Problem Description
On 24 january 2024, the complainant contacted leica biosystems with the following information: ¿hello, we are having a problem processing the biopsies, the material looks dry/burnt.Diagnoses are highly hampered by the quality of processing.I contacted [name] and she told me that we need to investigate and understand the reason for the problem in order to correct it correctly.Grateful!¿.On 02 february 2024, the local leica field applications specialist (fas) documented the following information regarding the circumstances involved in this event: ¿the customer complaint is that the protocol for biopsy samples needs to be adjusted.¿ on 02 february 2024, leica biosystems melbourne received information from the local leica field applications specialist that ¿no patient was affected and all samples were diagnosed.¿ no adverse consequence(s) to a patient(s) has been reported to the manufacturer.On 16 february 2024, the fas documented ¿i looked at the logs and didn¿t find anything that could explain the overprocessing.They used the factory 1-hour protocol with minor changes on the ethanol 70% step suggested by [leica manager, global technical support - applications] to avoid formalin salt formation.¿ on 08 march 2024, leica biosystems melbourne received additional information from the fas regarding the circumstances of this event: ¿customer reported that biopsy samples were overprocessed.During the application visit, the pathologist reported that only colon samples and small lymph nodes (1 mm) were overprocessed.Colon biopsy samples were processed on the ¿[protocol name]¿ (factory with a 70% ethanol step of 10 min), while lymph nodes were processed using the ¿[protocol name]¿ protocol.Reagents are being exchanged properly, and the procedures for instrument cleaning and maintenance are being performed.¿ the fas recommended ¿considering the size of the tissue described by the pathologist as poorly processed, the use of a factory protocol of 1h was suggested.It was also recommended that the 1 mm lymph nodes should be processed in the short protocol (1h).¿ the fas documented ¿for my finding, i think the root cause here is that the wrong processing scheduling is being used¿ the customer uses a modified 2h factory protocol.¿ the fas also documented the affected patient tissue type(s) and size(s) were ¿colon biopsy samples and small lymph nodes¿ and ¿1.5mm¿, respectively.The tissue artefact was described as ¿dry tissue at microtomy.In microscopy, tissue is shriveled [sic] and with poor nuclear detail and substantial shrinkage.¿ no details were provided regarding the specific tissue processing runs resulting in sub-optimal tissue processing.

• 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, vic; AS 0000003149 ; 92117271
• MDR Report Key: 19048151
• Report Number: 8020030-2024-00015
• Device Sequence Number: 8472344
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)200514
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/05/2024

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: 03/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• 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