MalfunctionHCF
COR-KNOT
Received Sep 27, 2024 · Event occurred Apr 11, 2024
Report 20321121 · MDR key 20321121
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Lsi Solutions, Inc.Model number
031082Catalog number
031082
Lot number
2277968
Patient
1 MO · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EVENT REPORT FOR A MEDICAL DEVICE MALFUNCTION (COR-KNOT DEVICE) REF # 031082, LOT # 2277968. WHEN THE CST GAVE THE DEVICE TO THE SURGEON, SHE SAID IT WAS HARD TO PRESS AND DEPLOY THE KNOT, AND THE COR-KNOT WAS HARD TO REMOVE FROM THE TIP. DEVICE SENT WITH THE ORIGINAL PACKAGE TO SUPPLIES DEPARTMENT.