inforMED

IP BIOPSY CASSETTE II

Received Oct 12, 2011 · Event occurred Aug 8, 2011

Report 2306165 · MDR key 2306165

Device

Generic name

Biopsy Cassettes

Manufacturer

Leica Biosystems

Model number

*

Catalog number

38440500

Lot number

M506TIP

Product problems

  • Break
  • Failure to Obtain Sample

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A TISSUE CASSETTE WAS NOTED TO HAVE NO TISSUE INSIDE. A PIECE OF THE CASSETTE WAS NOTED TO BE MISSING. ALL BIOPSY CASSETTES WILL BE TAKEN OUT OF SERVICE AND TISSUES CASSETTES WITH SPONGES WILL BE USED.