LIGASURE MARYLAND 44CM FT10 COMPATIBLE
Received Oct 16, 2024 · Event occurred Sep 18, 2024
Report 3032391-2024-00006 · MDR key 20463457
Device
Generic name
Ligasure Maryland 44cm Ft10 Compatible
Manufacturer
Medline RenewalCatalog number
LF1944CRH
Lot number
524171
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON 9/18/2024, THE DEVICE WAS NOT VESSEL SEALING CORRECTLY. IT WOULD NOT CAUTERIZE COMPLETELY AND THE VESSELS WERE STILL SLIGHTLY BLEEDING. THE FACILITY STATED THAT THERE WAS NO ADVERSE PATIENT REACTION OR PATIENT INJURY AND ANOTHER REPROCESSED LIGASURE WAS PULLED WITH NO ISSUES". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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.
Description of Event or Problem
ACCORDING TO THE FACILITY ON 9/18/2024, THE DEVICE WAS NOT VESSEL SEALING CORRECTLY.