LF1212ACRH
Received Oct 19, 2022 · Event occurred Sep 7, 2022
Report 3032391-2022-00012 · MDR key 15635973
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY ON (B)(6) 2022, 'WHEN THE LIGASURE WAS BEING USED, IT SMOKED, AND A PIECE OF MELTED PLASTIC WAS NOTED IN THE JAWS'.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2022, 'WHEN THE LIGASURE WAS BEING USED, IT SMOKED, AND A PIECE OF MELTED PLASTIC WAS NOTED IN THE JAWS'. PER THE FACILITY THEY WERE ABLE TO USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY OR MEDICAL INTERVENTION. THE SAMPLE IS AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.