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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA MICROSYSTEMS PELORIS RAPID TISSUE PROCESSOR

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LEICA MICROSYSTEMS PELORIS RAPID TISSUE PROCESSOR Back to Search Results
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.

 
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Brand NamePELORIS RAPID TISSUE PROCESSOR
Type of DeviceTISSUE PROCESSOR
Manufacturer (Section D)
LEICA MICROSYSTEMS
1700 leider lane
buffalo grove IL 60089
MDR Report Key7134689
MDR Text Key95594756
Report Number7134689
Device Sequence Number1
Product Code IEO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received12/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPELORIS II
Device Catalogue Number26.008
Device LOT NumberRETORT 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 FDA12/07/2017
Distributor Facility Aware Date11/16/2017
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer11/29/2017
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/11/2017 Patient Sequence Number: 1
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