Description of Event or Problem · 1
THE ANVIL FROM THE PROXIMAL COLON WAS ATTACHED TO THE STAPLER. THE STAPLER WAS THEN CLOSED AND FIRED. UPON FIRING THE STAPLER, THE TWO ENDS OF THE COLON CAME APART. ON EXAMINATION OF THE OPERATIVE FIELD, THERE WERE MULTIPLE STAPLES THAT HAD NOT FORMED INDICATING THAT THE STAPLER HAD NOT FUNCTIONED PROPERLY. ALL THE STAPLERS WERE TAKEN OUT OF THE OPERATIVE FIELD. AT THAT POINT, THE SURGEON WAS ABLE TO GRAB THE DISTAL RECTAL STUMP AND THE COLOSTOMY CREATED BY THE STAPLER. A SECOND STAPLER WAS THEN BROUGHT UP THROUGH THE RECTUM. THE TWO ENDS OF THE COLON WERE ATTACHED AND AGAIN THE STAPLER WAS FIRED; HOWEVER, THE STAPLES HAD NOT FORMED. UPON EXAMINATION, AGAIN, THERE WERE MULTIPLE UNFORMED STAPLES IN THE OPERATIVE FIELD, WHICH WERE REMOVED AND WERE GIVEN TO THE ETHICON REPRESENTATIVE FOR EVALUATION AT THE COMPANY. A THIRD STAPLER WAS THEN INTRODUCED INTO THE OPERATIVE FIELD. THE ANVIL WAS THEN ATTACHED TO THE POST AND THE STAPLER WAS CLOSED AND FIRED. UPON FIRING IT APPEARED THAT ON THE RIGHT SIDE, THE STAPLES DID FORM, BUT ON THE LEFT SIDE, THE STAPLES DID NOT FORM. THE SURGEON THEN DECIDED TO SUTURE THE TWO ENDS OF THE COLON. THE SKIN INCISION WAS THEN CLOSED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. MANUFACTURER RESPONSE FOR ETHICON INTRALUMINAL CIRCULAR STAPLERS, CDH (PER SITE REPORTER): NO RESPONSE YET.