inforMED
MalfunctionHCF

COR-KNOT®

Received Oct 30, 2024 · Event occurred Jul 23, 2024

Report 20565788 · MDR key 20565788

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Catalog number

031087

Lot number

1562344

Patient

51 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

COR KNOT LOADS GRINDING AND DID NOT LOAD PROPERLY. APPEARED THAT THE BLADE WAS NOT FULLY DISENGAGING. ONE JAMMED AND MISFIRED. NO HARM TO PATIENT. OPENED A NEW ONE. INCIDENT HAS BEEN REPORTED TO LSI & RETURNED. RGA#, TRACKING#. MANUFACTURER RESPONSE FOR COR KNOT DEVICE, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA#