CORE-KNOT SUTURE FASTENER

Description of Event or Problem

"COR NOT DEVICE" LOT #862774 REF#030800 OPENED FOR AVR CASE. -DEVICE MISFIRED, PULLING SUTURE/PLEDGET, SURGEON HAD TO REMOVE THE SUTURE AND PLEDGETS, ENSURE ALL THE PLEDGETS WERE ACCOUNTED FOR AND RESEW BACK IN. NEW DEVICE OPENED WITH SAME LOT NUMBER, NOT BEING ABLE TO BE LOADED CORRECTLY. THIRD DEVICE OPENED WITH DIFFERENT LOT NUMBER AND WORKED CORRECTLY. DEVICE ISSUE CAUSED INCREASED CASE TIME/TIME ON BYPASS. REPORTED TO OR(OPERATING ROOM) MANAGERS REF# 030800, THE LOT# 862774, EXP DATE 07-31-2025, QTY WAS 2 PER BX. TOTAL OF 4 TO RETURN; ITEMS USED WERE DISPOSED OF - PLAN TO RETURN REMAINING PACKAGE TO THE MANUFACTURER FOR REFUND AND INFORM THEM OF ISSUES AT THAT TIME (NOT YET DONE AS OF 08/23/2024). REF REPORT: MW5159046.