MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD. HISTOCORE PELORIS 3 TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number HISTOCORE PELORIS 3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation by leica biosystems to elucidate the root cause of the sub-optimal tissue processing reported by the complainant is in progress.

Event Description

A leica field support scientist (fss) received a complaint that breast, ganglion and skin samples, which had been processed in either retort a or b using one of "biopsie 4h or xylene 12h cgfl or routine" protocols, showed "some craters in the center of the tissues".Information documented by the fss detailed that all cases from which tissue samples exhibited sub-optimal processing were diagnosable; and re-biopsy of a patient had not been either recommended or performed.

Manufacturer Narrative

The root cause of the sub-optimal tissue processing identified by the complainant could not be unequivocally determined from the information available.It is considered that factors contributing to the sub-optimal tissue processing described by the complainant may include: the protocol structure not being optimized in relation the number and duration of steps; step temperature and pressure settings; and protocol carryover.The complainant did not provide specific details of the processing runs from which sub-optimal tissue processing was identified, but indicated that the tissue in all processing runs using the "biopsy 4h / xylene 12h cgfl / routine" protocols executed in both retort a and b was adversely impacted.Manufacturer evaluation of the instrument logs indicates that the laboratory runs predominantly the "biopsy 4h" and "routine" protocols, both which have been customized by the laboratory as detailed below: the "biopsy 4h" protocol has been customized such that the temperature setting for all dehydration and clearing steps is lower than that recommended by the manufacturer; all wax infiltration steps are configured to be performed under pressure rather than the manufacturer recommendation of vacuum; and the stirrer has been set to low rather than the manufacturer recommendation of medium.This configuration may lead to clearant (toluene) remaining in the tissue, which may result in both increased carry-over of clearant into wax and sub-optimal wax infiltration.- the "routine" protocol has been customized for eight (8) dehydration steps rather than the manufacturer recommendation of six (6) dehydrations steps.This may result in possible reagent scheduling conflicts.Investigation of this complaint found that the instrument operated within specification between (b)(6) 2019, which is the period covered by the instrument logs provided.

• Brand Name: HISTOCORE PELORIS 3 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
• MDR Report Key: 9367552
• MDR Text Key: 197329595
• Report Number: 8020030-2019-00046
• 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: 12/23/2019

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: HISTOCORE PELORIS 3
• Device Catalogue Number: 45.0001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 11/24/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 12/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1