• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA MICROSYSTEMS PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LEICA MICROSYSTEMS PELORIS RAPID TISSUE PROCESSOR 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 Known Impact Or Consequence To Patient (2692)
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 hemicolectomy procedure of the right colon from pt (b)(6) were processed overnight on the 8 hr processing protocol run in retort a on the leica peloris ii tissue processor instrument. Upon subsequent slide production, the tissue samples were found to be excessively dry and brittle and significantly over-processed. Although the confirmation of adenocarcinoma was made from the h&e stained slides, subsequent immunohistochemistry (ihc) stains for mismatch repair protein were not successful. These stains were performed twice in our laboratory and a third time at a reference lab facility. None were successful due to the sub-optimal processing of the tissue processor. This has significant implications related to the treatment of the pt as a pathologic recommendation for this diagnosis cannot be made without the ihc stains. Notations of the processing problem were noted in the pathology report and an internal rca was filed. 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, problems 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePELORIS RAPID TISSUE PROCESSOR
Type of DeviceTISSUE PROCESSOR
Manufacturer (Section D)
LEICA MICROSYSTEMS
1700 leider lane
buffalo grove IL 60089
MDR Report Key7134482
MDR Text Key95594989
Report Number7134482
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 A 8HR 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
-
-