EEA

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A SIGMOID COLON RESECTION PROCEDURE, THE DEVICE STAPLER USED AND FIRED. HOWEVER POST-OPERATIVELY, THE PATIENT CAME INTO THE EMERGENCY ROOM. THEY FOUND OUT THAT THE STAPLE LINE WAS DISRUPTED ON THE ANTERIOR SIDE AND ABOUT 1/3 OF THE ANASTOMOSIS WAS OPENED ON THE STAPLE LINE. THEY ALSO FOUND OUT THAT A LARGE LEAK WAS PRESENT, BUT THE TISSUE DID NOT APPEAR ISCHEMIC. TO RESOLVE THE ISSUE THE SURGEON HAD TO GIVE THE PATIENT A COLOSTOMY AND WILL NEED TO DO A FOLLOW-UP OPERATION. DUE TO THE PROBLEM THE PATIENT EXTENDS HOSPITAL STAY FOR ABOUT 3-4 DAYS.