MalfunctionHCF

COR-KNOT MINI

Received Nov 15, 2024 · Event occurred Oct 9, 2024

Report 20693892 · MDR key 20693892

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

4189099

Patient

67 YR · Female

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

Narrative

Description of Event or Problem

CORKNOT NEEDLES WOULDN'T LOAD PROPERLY INTO DELIVERY DEVICE. WOULDN'T SEAT AS NEEDED. NO PATIENT HARM. NEW BOX OPENED. MANUFACTURER RESPONSE FOR COR KNOT NEEDLE DEVICE, (BRAND NOT PROVIDED) (PER SITE REPORTER). VENDOR ASSIGNED A COMPLAINT/RGA NUMBER AND REQUESTED PRODUCT TO BE RETURNED FOR INVESTIGATION. CREDIT TO BE PROVIDED.