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

Model Number PELORIS II

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

Leica biosystems received a complaint regarding ineffective dehydration of tissue samples.On 25 july 2016, leica biosystems melbourne received confirmation from customer care that all tissue samples involved in this event were able to be diagnosed without further medical or surgical intervention.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

On-site assessment of the operation and function of the instrument was conducted by a leica field service engineer (fse) on 06 july 2016.The fse performed system verification tests, for which all results were satisfactory; and the instrument was found to be operating within specification.The fse advised the complainant to replace all the reagents on the instrument, including the waxes, prior to processing of diagnostic tissue samples.Manufacturer evaluation of the available instrument logs showed that: at 08:58am on (b)(6) 2016, a user commenced a manual fill operation of retort a using the reagent from bottle 6 (ethanol).This operation completed successfully at 08:59am on (b)(6) 2016.At 09:04am on (b)(6) 2016, a user commenced a manual drain operation of retort a to bottle 6 (ethanol).This operation completed successfully at 09:06am on (b)(6) 2016.A code recorded on two (2) occasions at 09:07am on (b)(6) 2016 indicates that the "a program" protocol, which was being scheduled by the user in retort a, could not be run because the first reagent scheduled for this protocol (formalin) was incompatible with residue remaining in the retort from the most recently used reagent, which was ethanol in this instance.The following information was displayed in association with this error code: "incompatible reagent in retort.Clean retort or edit protocol, retort a." at 09:08am on (b)(6) 2016, a user edited the "a program" protocol to commence at the final dehydration step.This modified protocol comprised one (1) dehydration step, three (3) clearing steps and three (3) wax infiltration steps.Based on information provided by the complainant, it was determined that the sub-optimal tissue processing reported was derived from the modified "a program" protocol started in retort a at 09:09am on (b)(6) 2016, which completed successfully at 13:52am on (b)(6) 2016.This protocol comprised 300 cassettes based on information entered by the user into the instrument software.Investigation of this complaint found that the instrument functioned as designed during execution of the modified "a program" protocol started in retort a at 09:09am on (b)(6) 2016.The root cause of the sub-optimal tissue processing reported was a use error, which occurred when the "a program" protocol was modified to comprise a single dehydration step only prior to three (3) clearing steps and three (3) wax infiltration steps.A single dehydration step is not sufficient to dehydrate the tissue samples.Incomplete dehydration of the tissue samples would have lead to incomplete clearing and wax infiltration of the tissue samples and resulted in the sub-optimal tissue processing reported.

• 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, victoria 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149 ; 92117535
• MDR Report Key: 5842287
• MDR Text Key: 52181940
• Report Number: 8020030-2016-00037
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/04/2016

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
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2012
• 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