ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THE COATING WAS "MORE STICKY" TO WHERE IT DOESN'T CLEARLY LET GO OF THE TISSUE AFTER SEALING AND CUTTING, THEREFORE CAUSING MORE BLEEDING AND OOZING. ALSO CAUSING MORE PLUME INSIDE THE ABDOMEN. STATED THE REFURBISHED DOES NOT LAST LONG ENOUGH FOR HER CASES AND NOT GOOD AT THE MOST IMPORTANT PART OF DISSECTION WITH KIDNEYS. THE SAME ISSUES HAPPENED WITH THE PRIOR REFURBISHED LIGASURE SHE WAS ASKED TO USE IN THE PAST.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THE COATING WAS "MORE STICKY" TO WHERE IT DOESN'T CLEARLY LET GO OF THE TISSUE AFTER SEALING AND CUTTING, THEREFORE CAUSING MORE BLEEDING AND OOZING. ALSO CAUSING MORE PLUME INSIDE THE ABDOMEN. THE BLOOD LOSS WAS MINIMAL, AND NO TRANSFUSION OR UNANTICIPATED MEDICAL TREATMENT WAS REQUIRED. THE PROCEDURE WAS NOT DELAYED AND WAS ULTIMATELY COMPLETED SUCCESSFULLY AFTER THE DEVICE WAS REPLACED MID PROCEDURE WITH AN OEM DEVICE. STATED THE REFURBISHED DOES NOT LAST LONG ENOUGH FOR HER CASES AND NOT GOOD AT THE MOST IMPORTANT PART OF DISSECTION WITH KIDNEYS. THE SAME ISSUES HAPPENED WITH THE PRIOR REFURBISHED LIGASURE SHE WAS ASKED TO USE IN THE PAST. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. 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.