GREEN JET ROUTINE I TAPED CASS NO/LID
Received Nov 14, 2024 · Event occurred Oct 18, 2024
Report 1419341-2024-00018 · MDR key 20683034
Device
Generic name
Cassettes, Tissue
Manufacturer
Leica BiosystemsModel number
GREEN JET ROUTINE I TAPED CASS NO/LIDCatalog number
38440002
Lot number
A02034936
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G6 AND H6 CODES WERE UPDATED. THE DEVICE WAS UNABLE TO BE TESTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. A CUSTOMER RETURNED WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
THE CUSTOMER REPORTED ON (B)(6) 2024 THAT THE METAL LIDS DO NOT FIT SECURELY ON GREEN JET ROUTINE I TAPED CASS NO/LID, P/N 38440002, LOT A02034936 WHICH CAUSED TISSUE HAS ESCAPED INTO PROCESSOR RETORT. THERE WAS NO REPORT OF TISSUE LOSS.
Additional Manufacturer Narrative
SUBMISSION 1419341-2024-00018 FOLLOW-UP 1 WAS MISSING THE AWARENESS DATE IN SECTION G3/4. THE CORRECT DATE WAS 22 JANUARY 2025.