TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM
Received Feb 27, 2018 · Event occurred Jan 19, 2018
Report 2083544-2018-00004 · MDR key 7300749
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Distress
- Distress
Narrative
Additional Manufacturer Narrative
THE FOAM IS INSERTED IN THE CASSETTE AS A CONVENIENCE FOR THE LAB TECHNICIANS. DUE TO THE NATURE OF THE FOAM, THE FOAM MAY DETACH FROM THE CASSETTE LID. AS SUCH SAKURA HAD ADDED A WARNING LABEL TO EACH BOX AS AN ADDITIONAL SAFETY FACTOR TO FURTHER WARN THE USER TO ENSURE THE FOAM IS IN PLACE BEFORE USE. FURTHERMORE, IT IS REQUIRED BY THE OPERATING MANUAL, AND TRAINING PROVIDED TO THE TECHNICIANS TO PLACE THE TISSUE ON THE FOAM IN ORDER TO ENSURE THE PRESENCE OF THE FOAM. TECHNICIANS ARE AWARE OF THIS AS THIS INFORMATION IS PRESENT IN THE INSTRUCTIONS FOR USE.
Description of Event or Problem
ON (B)(6) 2018, SAKURA FINETEK USA, INC. WAS NOTIFIED THAT A USER LOST A PATIENT'S SPECIMEN (CARDIAC BIOPSY) ON (B)(6) 2018. A GROSSING TECHNICIAN USED A SAKURA'S 13X13 BIOPSY PARAFORM INSERT (PRODUCT CODE 7019) WITHOUT NOTICING THE SPONGE IN THE LID WAS MISSING. THE SPECIMEN WAS LOST DURING PROCESSING ON A PELORIS PROCESSING INSTRUMENT BY (B)(6).