It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, the surgeon grasped the bowel using a vessel seal extend (vse) and perforated the bowel.The surgeon stated using a tip-up fenestrated grasper in one hand and a vse in the other hand, to examine and to count the small bowel (run the bowel).Feeding the small bowel hand over hand, the surgeon counts in centimeters (cm) to assure there is enough length after creating the pouch for the stomach.When the surgeon went to grasp the small bowel with the vse, a hole was created.The bowel perforation was sutured closed.The procedure was completed robotically.There were no post operative complications.The csr has since discussed with the surgeon, prior to running the bowel, about switching from a vse instrument to using another fenestrated tip-up grasper instrument.The surgeon has since switched to using two fenestrated tip-up grasper instruments for running the bowel; and in the last six cases, there's been no issues.
|
An rma was not issued for return as the customer reported that the instrument was disposed; therefore, failure analysis cannot be performed.The log review shows for product number 480422-01, lot number k17230810-0304, was installed on the system four times and passed homing four times.There were 44 cut events that were completed without any errors.The e-100 logs show there were 36 seal events and 2 coag events that were completed without error.There were no errors in the logs for this procedure.
|