LF1212AC @LIGASURE SM JAW INSTRUMENT
Received Feb 5, 2020 · Event occurred Jan 4, 2020
Report 3032391-2020-00001 · MDR key 9672404
Device
Product problems
- Physical Resistance/Sticking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING A BILATERAL SALPINGECTOMY, THE LIGASURE JAW WAS IDENTIFIED TO BE DIFFICULT TO RELEASE. REPORTEDLY, DURING RELEASE THE LIGASURE JAW STUCK TO THE LEFT FALLOPIAN TUBE AND THE PATIENT EXPERIENCED BLEEDING TO THE SITE. THE BLEEDING WAS ABLE TO BE CONTROLLED, HOWEVER, AN ADDITIONAL THIRTY (30) MINUTES WERE ADDED TO THE PROCEDURE AND THE PATIENT RECEIVED ADDITIONAL ANESTHESIA. THE METHOD UTILIZED TO CONTROL THE REPORTED BLEEDING WAS NOT IDENTIFIED BY THE REPORTING FACILITY. NO SERIOUS INJURY, ADDITIONAL MEDICAL INTERVENTION, OR FOLLOW-UP CARE WAS REPORTED. NO SAMPLE WAS RETURNED FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION, 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 JAW WAS IDENTIFY TO BE DIFFICULT TO RELEASE.