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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR
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LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR Back to Search Results
Model Number PELORIS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 10/02/2019
Event Type  Injury  
Event Description
Leica biosystems received a complaint regarding over-processed tissue.On (b)(6) 2019, a leica representative received the following information from the complainant: "the tissue involved was a lung biopsy that was less than.1 mm in diameter.The pathologist stated that the sample was damaged such that she could tell it was malignant, but was unable to determine the origin or the tumor type adequately enough to properly order subsequent ancillary testing.The scant nature of the specimen also makes additional ihc for tumor specificity limited." re-biopsy for the one (1) case had not been recommended or performed as of this report.If additional information is obtained a follow up report will be submitted.
 
Event Description
On (b)(6) 2019, leica biosystems received the following information from the complainant: "the case was sent out for consult and ihc stains performed.Through both the consult and the stains, we got an answer.This patient does have a confirmed diagnosis.".
 
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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, 3149
AS  3149
MDR Report Key9267401
MDR Text Key165637780
Report Number1423337-2019-00012
Device Sequence Number1
Product Code IEO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPELORIS
Device Catalogue Number26.0005
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2019
Distributor Facility Aware Date10/02/2019
Event Location Hospital
Date Report to Manufacturer11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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