MalfunctionKER
IP BIOPSY CASSETTE II
Received Nov 17, 2011 · Event occurred Aug 5, 2011
Report 1419341-2011-00001 · MDR key 2372035
Device
Generic name
Tissue Cassette
Manufacturer
Leica B Iosystems RichmondModel number
38440500Catalog number
38440500
Lot number
130205369
Product problems
- Component Missing
Patient
Not reported
- No Information
Narrative
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.
Description of Event or Problem
CUSTOMER REPORTED THAT AFTER PROCESSING, A TISSUE CASSETTE WAS MISSING A PIECE AND THE TISSUE WAS FOUND AT THE BOTTOM OF THE PROCESSOR. NO RE-BIOPSY OF THE PATIENT WAS REQUIRED AND THIS EVENT DID NOT AFFECT THE DIAGNOSIS.