MAUDE Adverse Event Report: LEICA MICROSYSTEMS PELORIS RAPID TISSUE PROCESSOR

Model Number PELORIS II

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Code Available (3191)

Event Date 11/16/2017

Event Type  Injury  

Event Description

Surgical tissue samples submitted for pathology evaluation were severely over-processed by the tissue processor instrument.The subsequent glass microscopic slides produced were inadequate for rendering a pathologic diagnosis.Tissue from a bladder tumor resection from pt (b)(6) was processed overnight on the 6 hour processing protocol run in retort b on the leica peloris ii tissue processor instrument.Upon subsequent slide production, the tissue samples were found to be excessively dry and brittle and the histologists were unable to section a satisfactory rep section of the sample.Dry, broken sections of tissue (from microtomy) were placed on the microscopic slides and stained by h&e method.Upon review of the slides by the pathologist, she deemed that the sample was undiagnosable.Notations of the tissue processing problem/artifact were noted in the pathology report and an internal rca was filed.The pathologist forwarded the slides to another healthcare facility for secondary review and a consult diagnosis was issued, again with the tissue processing problem/artifact noted in that pathology report.Although a diagnosis was rendered, the disclaimer noted by the facility pathologist and consulting pathologist indicate the difficulty in confirming the diagnosis.The need for extended review by the facility pathologist, as well as the need for consultation due to the tissue processing deficiency delayed the reporting of pathology results which did delay treatment for the pt.An internal review of the leica peloris ii tissue processor instrument's error codes and processing run data did not indicate an obvious malfunction.However, problem with dry, brittle tissue samples and over-processing have been reported to the mfr since the purchase of the instrument and most recently on various dates from (b)(6) 2017.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA MICROSYSTEMS ; 1700 leider lane; buffalo grove IL 60089
• MDR Report Key: 7134689
• MDR Text Key: 95594756
• Report Number: 7134689
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.008
• Device Lot Number: RETORT B 6HR PROTOC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2017
• Distributor Facility Aware Date: 11/16/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other