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

Model Number PELORIS

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 11/02/2016

Event Type  malfunction  

Event Description

On 02 november 2016, leica biosystems received a complaint that: "the tissue in both retorts, especially the biopsy tissue is fried." the complainant advised that some of the tissue samples involved were diagnosable without further action while other tissue samples needed to be re-cut after soaking.On 04 november 2016, leica biosystems received information that all tissue samples exhibiting sub-optimal tissue processing were diagnosable.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

On (b)(6) 2016, leica biosystems received a complaint that: "the tissue in both retorts, especially the biopsy tissue is fried." the complainant advised a leica field support specialist (fss) that sub-optimal tissue processing had been identified for a period of three (3) weeks prior to initiation of this complaint; some of the tissue samples involved were diagnosable without further action, while other tissue samples needed to be re-cut after soaking and the affected tissue samples were described as "over-processed".The complainant also expressed concern that the reagent in bottle 9, which had been replaced on (b)(6) 2016 and diluted to 70%, had a concentration of 56% when measured with a hydrometer following completion of two (2) processing runs.On (b)(6) 2016, a fss attended the laboratory in order to obtain further details of the circumstances involved in this complaint and to provide applications support.The fss documented the presence of a large amount of salt crystals, a fatty substance and "sludge" in a number of reagent bottles; the absence of a gasket from bottles 5 and 16 and that the variance between the measured and calculated ethanol concentration in bottles 4, 6 and 9 exceeded the acceptable limit.The fss emptied, cleaned and then replaced the reagent in all bottles.Investigation of this complaint found that the instrument functioned as designed between (b)(6) 2016, which is the period that sub-optimal tissue processing was reported by the complainant.The root cause of the sub-optimal tissue processing reported is considered likely to be a combination of use errors.Specifically, failure to follow the manufacturer instructions detailed in the leica peloris/peloris ll user manual in relation to cleaning and maintenance of the reagent bottles as evidenced by the presence significant amounts of foreign material contaminating several bottles; and failure to follow the manufacturer instructions detailed in the leica peloris/peloris ll user manual in relation completion of the manual reagent replacement process.These use errors may impact the accuracy of the reagent concentration calculated by the instrument software.

• 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: 6137334
• MDR Text Key: 61501298
• Report Number: 8020030-2016-00082
• 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,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem 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: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2007
• 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