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

Model Number PELORIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

A leica biosystems representative from north america technical support who contacted the complainant on 09 november 2016, was advised that no action was required from leica biosystems; and the offer of support/assistance was refused.Based on the information provided by the complainant that the sub-optimal tissue processing was resolved following replacement of the "70% alcohols", it is considered possible that the interaction between the device and the user either caused or contributed to the sub-optimal tissue processing reported.As a consequence of this possible use error involving completion of the reagent replacement process, it was determined that the available information meets the regulatory agency reportability criteria because the circumstance described has previously caused a serious injury.

Event Description

Leica biosystems received a complaint that prostate biopsy samples in six (6) cassettes, which had been processed in a protocol executed in retort b, which completed at 07:00 am, were "hard to cut." the complainant advised that a total of 82 cassettes had been processed in the affected protocol; and the tissue samples in the remaining 76 cassettes, which were gastro-intestinal biopsy samples, were not adversely affected.The complainant also advised that no complaint(s) had been received regarding the morphology of the affected samples; all specimens were diagnosable; no error(s) had been recorded during execution of the affected protocol and that: "70% alcohols were changed the problem was gone.".

• 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: 6128285
• MDR Text Key: 60942288
• Report Number: 8020030-2016-00081
• 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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2016
• 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: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2007
• 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