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	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 17 june 2024, the complainant contacted leica biosystems with the following information: ¿tissue impacted by cleaning protocol.Retort a had 3 baskets of cassettes, 214 specimens cleaning protocol performed before specimens removed¿.On (b)(6) 2024, the fas visited the complainant¿s site to assess the operation and function of the instrument and documented the following: ¿customer reported dry biopsies while embedding.Customer noticed that cleaning cycle was run before biopsies were removed from retort.Biopsies went through cleaning cycle on retort a¿customer reprocessing specimens offline, then ran specimens on same peloris unit through normal 1 hour processing protocol.Processing protocol on retort a completed at 9:59am.Specimens were not unloaded until around 11:30am.Specimens were sitting in drained retort for about 1.5 hours.In that time, one lab personnel started a cleaning cycle on retort a without checking to see if retort was emptied first.Maintenance on instrument is good.¿ the fas ¿highly recommended not having specimens sit in a hot retort for more than 15 minutes.This could cause heat damage to the tissue and negatively impact nuclear detail.This also leaves room for mistakes like running a cleaning protocol with specimens still inside retort.¿ on 18 june 2024, leica biosystems melbourne received the following information from the fas regarding patient outcome: ¿final patient tissue status is still unknown.¿ the fas documented the affected patient tissue samples were derived from one (1) ¿peloris - factory 2hr xylene protocol¿ comprising 214 cassettes which started in retort a at 11pm on 16 june 2024 and completed at 10am on 17 june 2024.The affected patient tissue type(s) and size(s) were documented as ¿biopsies¿ and ¿>3mm¿, respectively.The tissue artefact was described as ¿dry¿.The affected patient tissue samples were reprocessed via ¿reverse processing, then processed normally offline.¿ on 25 june 2024, leica biosystems melbourne received the following from the fas that all patient cases were diagnosable; and no re-biopsy was performed nor recommended.No adverse consequence(s) to any patient(s) has been reported to the manufacturer.
Additional Manufacturer Narrative
Investigation of this complaint found the instrument functioned as designed during the execution of the ¿factory 2hr xylene¿ which started in retort a at 12:13 on 15 june 2024 and completed successfully at 09:59 on 17 june 2024, from which sub-optimal processing of patient tissue samples was reported by the complainant.The information available details: ¿customer noticed that cleaning cycle was run before biopsies were removed from retort.Biopsies went through cleaning cycle on retort a.¿ evaluation of the instrument logs found the cleaning run executed subsequent to the completion of the affected run included the drying step, which had a duration of 12 minutes at a retort temperature of 80oc.The root cause for the reported ¿tissue impacted¿¿ was exposure of patient tissue samples to a retort cleaning cycle(s) including the dry step.Specifically, a user to follow the manufacturer instructions detailed in section 3.2 of the leica histocore peloris 3 user manual, which contains the following specific warnings: ¿load and run cleaning protocols like other protocols, but never put tissue in the retort ¿ the dry step will damage it.This means cleaning protocols should never be used for reprocessing runs ¿ use a reprocessing protocol instead.¿ and ¿remove all tissue from the retort before running a cleaning protocol as the dry step will damage the tissue.¿ and ¿do not use cleaning protocols for reprocessing as the dry step will damage the tissue.¿ although the information available indicates that all patient cases involved in this event were diagnosable, the circumstances involved in this complaint have previously resulted in serious injury.No adverse impact on either the quality of processing of patient tissue samples or to any patient(s) has been reported to the manufacturer in association with the circumstances involved in this complaint.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.

• 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: 19737895
• Report Number: 8020030-2024-00022
• Device Sequence Number: 7991656
• Product Code: IEO
• UDI-Device Identifier: 09349458004811
• UDI-Public: (01)09349458004811(11)231205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/15/2024

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: 06/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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