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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR
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LEICA BIOSYSTEMS MELBOURNE PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR Back to Search Results
Model Number PELORIS II
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/27/2014
Event Type  Injury  
Event Description
On (b)(6) june 2014, leica microsystems received information from the laboratory regarding the status of the tissue samples from which sub-optimal tissue processing was reported.The information received stated that re-biopsy of nine of these patients.Refer to mfr report #8020030-2014-00021 submitted for peloris ii tissue processor and 8020030-2014-00022, 8020030-2014-00023, 8020030-2014-00025, 8020030-2014-00026, 8020030-2014-00027, 8020030-201400028, 8020030-2014-00029, 8020030-2014-00030 for specific details of the other patient involved.
 
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Brand Name
PELORIS RAPID TISSUE PROCESSOR
Type of Device
AUTOMATED TISSUE PROCESSOR
Manufacturer (Section D)
LEICA BIOSYSTEMS MELBOURNE
495 blackburn rd.
mount waverley
victoria 3149
AS  3149
Manufacturer Contact
495 blackburn rd.
mount waverley
victoria 3149
92117400
MDR Report Key3934651
MDR Text Key4575922
Report Number8020030-2014-00030
Device Sequence Number1
Product Code IEO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPELORIS II
Device Catalogue Number26.0003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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