IP ACTIVFLO BIOPSY III, TAPED BLUE
Received Sep 17, 2020 · Event occurred Aug 20, 2020
Report 1419341-2020-00003 · MDR key 10550320
Device
Generic name
Ip Activflo Biopsy Iii, Taped Blue
Manufacturer
Leica BiosystemsModel number
NACatalog number
39LC-625-2-L
Lot number
V20190413-3
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. PRODUCT WAS DISCARDED BY THE CUSTOMER, THEREFORE, ADDITIONAL TESTING ON THE SLIDE CANNOT BE COMPLETED. NO RETAINS OR CURRENT INVENTORY WAS AVAILABLE, THEREFORE, ADDITIONAL TESTING COULD NOT BE COMPLETED. IF ADDITIONAL INFORMATION IS OBTAINED A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
ON (B)(6) 2020 THE CUSTOMER REPORTED ONE CASSETTE OF THE IP ACTIVFLO BIOPSY III, TAPED BLUE (39LC-625-2-L) LOT V20190413-3 WHICH HAD OPENED DURING PROCESSING CAUSING TISSUE LOSS THAT REQUIRED RE-BIOPSY OF THE PATIENT.