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

Model Number PELORIS II

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 09/13/2016

Event Type  Injury  

Event Description

Leica biosystems received a complaint that tissue in 167 cassettes processed showed poor morphology.The complainant reported that tissue was falling from the blocks; specimens were floating in the molds; the tissue samples were brittle and hard to cut; no errors had been displayed during processing; batch controls for haematoxylin and eosin were satisfactory and errors occurred during the cleaning cycle for retort b, which failed.On 22 september 2016, leica biosystems received information that seven (7) patients had been recommended for re-biopsy.An identifier, the age and the gender were provided for each of the patients recommended for re-biopsy.Refer to # 8020030-2016-00068; 8020030-2016-00070; 8020030-2016-00071; 8020030-2016-00072; 8020030-2016-00073; and 8020030-2016-00074 for specific details of the other patients involved.

Manufacturer Narrative

Investigation of this complaint found that: - the sub-optimal tissue processing reported by the complainant was derived from "5hr run" protocol started in retort b at 20:06pm on (b)(6) 2016, which comprised 168 cassettes, and completed successfully at 04:00am on (b)(6) 2016.- the reagent in bottles 4 (70% ethanol) and 12 (xylene) had been replaced prior to commencement of the "5hr run" protocol started in retort b at 20:06pm on (b)(6) 2016.No use error(s) was identified in the instrument logs in the interaction between the user and the instrument when completing manual replacement of either of the reagents.- the reagent in bottles 4 (70% ethanol) and 12 (xylene) was used for the first time in the second dehydration and the final clearing steps respectively of the "5 hr run" protocol started in retort b at 20:06pm on (b)(6) 2016.- the instrument was found to have operated within specification during execution of the "5hr run" protocol started in retort b at 20:06pm on (b)(6) 2016.The root cause of the sub-optimal tissue processing reported from the "5hr run" protocol started in retort b at 20:06pm on (b)(6) 2016 could not be determined from the information available.The root cause for failure of the cleaning cycle, which was run subsequent to completion of the "5hr run" protocol started in retort b at 20:06pm on (b)(6) 2016 from which the sub-optimal tissue processing was reported by the complainant, was a high level of contamination of the reagent in bottle 15 (cleaning xylene) with floating solid material.The specific composition of the floating solid material could not be determined from the instrument logs.Failure of the cleaning cycle is not considered to have either caused or contributed to the sub-optimal tissue processing reported.A leica field service engineer arranged for the contents of bottle 15 (cleaning xylene) to be replaced during attendance at the customer site on 14 september 2016; and subsequently verified that there was no remnant blockage in the instrument by performing the appropriate service tests.

• 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: 6078041
• MDR Text Key: 59119412
• Report Number: 8020030-2016-00069
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR