MEDLINE RENEWAL REMANUFACTURED LIGASURE EXACT
Received Dec 3, 2025 · Event occurred Oct 24, 2025
Report 3032391-2025-00009 · MDR key 23706688
Device
Generic name
Ligasure Exact Dissector Ft10 Compatible
Manufacturer
Medline RenewalCatalog number
LF2019CRH
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Female
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS USED DURING A PROCEDURE. NO ISSUES WERE NOTED DURING THE PROCEDURE. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH AN INFECTION, WAS HOSPITALIZED FOR 4 DAYS, UNDERWENT A NECK I&D, AND WAS DISCHARGED ON IV ANTIBIOTICS. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
THE DEVICE WAS USED DURING A PROCEDURE. NO ISSUES WERE NOTED DURING THE PROCEDURE. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH AN INFECTION, WAS HOSPITALIZED FOR 4 DAYS, UNDERWENT A NECK I&D, AND WAS DISCHARGED ON IV ANTIBIOTICS.
Remedial action
- Other
- Recall