MalfunctionIDZ
WHITE PROCESSING CASSETTES
Received Jan 11, 2012 · Event occurred Dec 12, 2011
Report 1419341-2012-00001 · MDR key 2441920
Device
Generic name
Tissue Cassette
Manufacturer
Leica Biosystems RichmondModel number
3850510ECatalog number
3850510E
Lot number
022211
Product problems
- Material Deformation
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT WARPING OF THE TISSUE PROCESSING CASSETTE IS CAUSING LIDS TO COME OFF DURING PROCESSING AND THE CUSTOMER HAS LOST A SPECIMEN AS A RESULT.
Additional Manufacturer Narrative
THE AFFECTED TISSUE PROCESSING CASSETTE WAS NOT RETURNED TO CONTINUE INVESTIGATION. THERE HAVE BEEN NO OTHER REPORTED INCIDENTS WITH THIS PRODUCT OF THIS NATURE.