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

Model Number PELORIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The laboratory did not provide specific details of the processing runs affected but indicated that sub-optimal tissue processing of 400 cassettes occurred on (b)(6) 2019 using the "small biopsy" protocol and the "routine" protocol in both retorts a and b.Manufacturer evaluation of the instrument logs for the 08 november 2019 showed that a total of four (4) processing runs using the "large bx /cell blocks, bone marrow,derm" protocol; and the "6 hr routine surgical cycle" protocol with a total of 273 cassettes either started or completed on (b)(6) 2019.Bottle 12 (xylene) was not in contact with the corresponding sensor for periods of approximately 13 seconds at 02:44am on (b)(6) 2019 and seven (7) seconds at 10:49am on (b)(6) 2019; neither of which is for sufficient time to replace the reagent.The station properties were reset at 10:53am on (b)(6) 2019, with a user affirming in the instrument software that the reagent concentration was to be set to be set to the default value of 100%.The properties of the reagent in bottle 12 prior to these user actions were: xylene concentration=98.5%, cycle=10, cassettes=607 and days=4.Although the user affirmed that the ethanol concentration in bottle 12 (xylene) was to be set to the default value of 100% at 10:53am on (b)(6) 2019, the actual xylene concentration would have remained unchanged at 98.5% because the bottle had not been removed from the instrument for sufficient time to replace the reagent.However, the final xylene threshold had been customized to 98% rather than the manufacturer recommended 95%.It is expected that the xylene concentration in bottle 12 following processing of 300 cassettes should decrease by approximately 1% only.The leica peloris/peloris ll 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." it is unlikely that the use error identified either caused or contributed to the sub-optimal tissue processing reported, because the minimum final reagent concentration required for xylene is 95%; and the actual reagent concentration would have not reached the minimum final reagent concentration.Manufacturer evaluation of the instrument logs for the (b)(6) 2019 showed that a total of four (4) processing runs using the "8 hr fatty (no fixative)" protocol and the "6 hr routine surgical cycle" protocol with a total of 551 cassettes either started or completed on (b)(6) 2019.Investigation of this complaint found that the instrument functioned as designed during execution of the processing runs executed on (b)(6) 2019.The root cause of the sub-optimal tissue processing on (b)(6) 2019 identified by the complainant could not be determined from the information available.

Event Description

The leica applications specialist - core histology received a complaint of "brittle tissue", which occurred on (b)(6) 2019.The complainant advised that 11 out of 58 cases have not been able to be diagnosed.On 03 december 2019, the leica applications specialist-core histology received the following information from the complainant in relation to the event on (b)(6) 2019: "there are eleven (11) cases that could potentially have repeat biopsies.Currently, there have been two repeat biopsy cases: (b)(6) y.O./female/vaginal bx ,(b)(6) y.O./female/endometrial bx.All cases able to be diagnosed?: no, 11 of 58 cases cannot be diagnosed." the following information was received in relation to the event on (b)(6) 2019: "currently, there have not been any repeat biopsy cases.There is one (1) cases that could potentially have a repeat procedure.All cases able to be diagnosed? no, one case cannot be diagnosed by pathology but was diagnosed by radiology." as at (b)(6) 2019, leica biosystems has not received any further information in relation to the other un-diagnosable cases.Refer to mfr.Report #8020030-2020-00003 for specific details of the other patient involved.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, 3149 ; AS 3149
• MDR Report Key: 9573359
• MDR Text Key: 188844599
• Report Number: 8020030-2020-00002
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR