YELLOW JET ROUTINE III TAPED CASSETTE W/LID
Received Apr 11, 2024 · Event occurred Mar 18, 2024
Report 1419341-2024-00003 · MDR key 19091757
Device
Generic name
Cassettes, Tissue
Manufacturer
Leica BiosystemsModel number
YELLOW JET ROUTINE III TAPED CASSETTE W/LIDCatalog number
38440203
Lot number
929137222
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
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. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. A CUSTOMER RETURNED SAMPLE ANALYSIS WAS COMPLETED. THERE IS NO DATA TO CONFIRM MANUFACTURING DEVIATION. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
ON (B)(6) 2024 THE CUSTOMER REPORTED YELLOW JET ROUTINE III TAPED CASSETTE W/LID, P/N 38440203, LOT 929137222 DID NOT PROPERLY CLOSE CAUSING THE CASSETTE TO OPEN IN THE PROCESSOR. GI BIOPSY TISSUE WAS LOST IN THE RAPID TISSUE PROCESSOR (RTP). THERE WAS OTHER CASSETTES WITH ADDITIONAL TISSUE. RE-BIOPSY WAS NOT REQUIRED FOR DIAGNOSIS.