MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number PELORIS II

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Information documented by the fss details the following for a processing run using the biopsy protocol executed in retort a on (b)(6) 2020: "customer reported underprocessed tissue.2 biopsy cassettes from different cases had tissue that appeared under processed when cut.No reprocess was done - pathologist asked for recuts - sections still suboptimal but diagnosis was rendered on both cases." further information documented by the fss details the following for one (1) cassette from a processing run using the biopsy protocol executed in retort a on (b)(6) 2020: "customer reported overprocessed tissue.Renal biopsy that seemed over processed/ very crunchy and difficult to cut.At the direction of the pathologist it was not re-processed--- additional cuts preformed [sic].Diagnosis was rendered." the complainant was not willing to provide instrument logs or allow site access due to the requirement for it involvement or to have visitors on site due to covid-19.Consequently, it was not possible for the manufacturer to conduct investigation of the circumstances involved in this event in order to determine the root cause of the sub-optimal tissue processing reported by the complainant.As at (b)(6) 2020, the root cause of the sub-optimal tissue processing reported by the complainant could not be determined from the information available.

Event Description

A leica applications specialist - core histology (fss) received a complaint of "underprocessed/overprocessed" tissue samples following completion of processing the following requests were made by the assigned fss requesting access to the customer site and/or for the customer to download instrument logs to enable conduct of the root cause investigation: 16 june 2020 by email; 19 june 2020 by email and telephone; 22 june 2020 by email; 30 june 2020 by email; 09 july 2020 by telephone and 13 july 2020 by email.On 14 july 2020, leica biosystems (b)(4) received the following information from the fss in relation to access to the customer site and/or the instrument logs: "i am unable to go on-site to this lab pending covid-19 testing.I have reached out numerous times and they are unable to provide logs due to it restrictions." information documented in the adverse event form by the leica applications specialist - core histology indicates onsite visit is scheduled for (b)(6) 2020.On 14 july 2020, leica biosystems (b)(4) received information from the leica applications specialist - core histology that all cases involved in this event were diagnosable.

Manufacturer Narrative

Based on the information provided on the (b)(6) 2020, the tissue samples exhibiting sub-optimal tissue processing were derived from the "3hr myocardial bx" protocol comprising 29 cassettes, which started in retort a at 19:34pm on (b)(6) 2020 and completed at 21:00pm on (b)(6) 2020; and the "3hr myocardial bx" protocol comprising 47 cassettes, which started in retort a at 19:10pm on (b)(6) 2020 and completed at 21:34pm on (b)(6) 2020.The laboratory defined "3hr myocardial bx" protocol with a duration of 2 hours and 26 minutes has been validated by the laboratory and was last modified on (b)(6) 2019.Information documented by the fss details that tissue samples exhibiting sub-optimal processing derived from the "3hr myocardial bx" protocol started in retort a at 19:10pm on (b)(6) 2020 were "mostly renal and 0.1-0.3cm." (this measurement is equivalent to 1-3mm.) section 8.2.1 of the leica peloris/peloris ii 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.Investigation of the instrument logs available from the (b)(6) 2020, found that the instrument operated within specification during execution of the "3hr myocardial bx" protocols started in retort a at both 19:34pm on (b)(6) 2020 and at 19:10pm on (b)(6) 2020, from which sub-optimal tissue processing was reported by the complainant.The manufacturer recommendations indicate that the "3hr myocardial bx" protocol with a duration 2 hours and 26 minutes is not appropriate for the "mostly renal and 0.1-0.3cm" samples reported as exhibiting sub-optimal processing from the protocol of this name started in retort a at 19:10pm on (b)(6) 2020.The findings suggest that the root cause of the sub-optimal tissue processing reported by the complainant in was use of a protocol of inappropriate duration for the size/type of the tissue samples being processed.

• Brand Name: PELORIS II RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 10280974
• MDR Text Key: 244803045
• Report Number: 8020030-2020-00030
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1