IP BIOPSY CASSETTE II, TAPED, WHITE
Received Jun 8, 2022 · Event occurred May 2, 2022
Report 1419341-2022-00003 · MDR key 14635501
Device
Generic name
Ip Biopsy Cassette Ii, Taped, White
Manufacturer
Leica BiosystemsModel number
N/ACatalog number
38440500
Lot number
924510138
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Tissue Breakdown
- Tissue Breakdown
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 RETAIN SAMPLE ANALYSIS WAS COMPLETED. THIS IS A ISOLATED INCIDENT, 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) 2022 THE CUSTOMER EXPERIENCED TISSUE LOSS WHILE USING THE IP BIOPSY CASSETTE II, TAPED, WHITE, P/N 38440500, LOT 924510138 WHICH OPENED EASILY DURING TISSUE PROCESSING. ON (B)(6) 2022 LEICA BIOSYSTEMS BECAME AWARE THAT THE PATIENT HAD TO BE RE-BIOPSIED FOR A DIAGNOSIS DUE TO NO ADDITIONAL TISSUE AVAILABLE.
Additional Manufacturer Narrative
D3 WAS CORRECTED TO INCLUDE THE MANUFACTURING ADDRESS. H5 WAS CORRECTED TO INCLUDE THIS IS LABELED FOR SINGLE USE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.