LIGASURE IMPACT FT10 COMPATIBLE
Received Aug 10, 2021 · Event occurred Jul 19, 2021
Report 3032391-2021-00015 · MDR key 12300349
Device
Product problems
- Device Ingredient or Reagent Problem
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE LIGASURE DEVICE WOULD NOT COAGULATE AND THE SURGEON UTILIZED SUTURES TO SEAL A CUT. AFTER SUTURING, THE SURGEON ATTEMPTED TO COAGULATE THE CUT AGAIN USING THE LIGASURE DEVICE AND, AT THAT TIME, COAGULATION WAS SUCCESSFUL. THE LIGASURE DEVICE WAS REPORTEDLY USED FOR THE REST OF THE PROCEDURE WITHOUT FURTHER INCIDENT. NO SERIOUS INJURY OR IMPACT TO THE PATIENT'S POST-OPERATIVE CARE OCCURRED. NO FURTHER MEDICAL INTERVENTION OR FOLLOW-UP CARE WAS REQUIRED. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION AND A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO SUTURE THE CUT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE LIGASURE DEVICE WOULD NOT COAGULATE.
Additional Manufacturer Narrative
A SAMPLE WAS RETURNED WITH EVALUATION COMPLETED ON 20-AUG-2021. THE DEVICE WAS NOT RETURNED WITH ITS PACKAGING AND NO LOT INFORMATION WAS NOTED. THE DEVICE WAS INSPECTED AND TESTED FOR NONCONFORMITIES. SIMULATED USE TESTING WAS PERFORMED USING BEEF TRIPE AND THE DEVICE WAS FOUND TO SEAL AND CUT THE TEST MEDIA AS EXPECTED WITH AN EFFECTIVE SEAL OBSERVED. THE REPORTED PROBLEM/ISSUE COULD NOT BE REPLICATED OR CONFIRMED AND A ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.