LIGASURE SMALL JAW FT10 COMPATIBLE
Received Nov 2, 2022 · Event occurred Oct 1, 2022
Report 3032391-2022-00013 · MDR key 15716815
Device
Generic name
Ligasure Small Jaw Ft10 Compatible
Manufacturer
Medline RenewalCatalog number
LF1212ACRH
Lot number
479863
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY DURING A TUBAL LIGATION THE TISSUE WAS STICKING TO THE TEFLON COATED JAWS OF THE DEVICE CAUSING THE TISSUE TO BE RIPPED AND BLEEDING TO OCCUR.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY DURING A TUBAL LIGATION THE TISSUE WAS STICKING TO THE TEFLON COATED JAWS OF THE DEVICE CAUSING THE TISSUE TO BE RIPPED AND BLEEDING TO OCCUR. PER THE FACILITY THE PATIENT REQUIRED SUTURES TO STOP THE BLEED. THE SAMPLE WAS RETURNED FOR EVALUATION AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.