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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 Problems Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2014
Event Type  malfunction  
Event Description
Leica biosystems received a complaint regarding sub-optimal tissue processing from one (1) protocol, which required re-processing of the tissue samples involved.The complainant advised that the affected tissue samples smeled strongly of formalin; formalin had leaked into the wax and that the wax was contaminated.The leica field service engineer (fse) who attended the lab on (b)(6) 2014 confirmed contamination of the wax baths with "water".On (b)(4) 2014, leica biosystems received info that all tissue samples exhibiting sub-optimal processing were diagnosable.Investigation of this complaint by leica biosystems is in progress.
 
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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 rd.
mount waverley, victoria 3149
AS  3149
Manufacturer Contact
495 blackburn rd.
mount waverley, victoria 3149
92117535
MDR Report Key4474754
MDR Text Key22028267
Report Number8020030-2014-00078
Device Sequence Number1
Product Code IEO
Combination Product (y/n)N
Reporter Country CodeAS
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 11/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPELORIS
Device Catalogue Number26.0001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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