PLATE, BASE, SHELLAC

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT AN LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE. THE CIRCULAR STAPLER WAS USED DURING THE LAST STEP OF THE SURGERY TO CREATE THE ANASTOMOSIS BETWEEN THE DISTAL COLON AND RECTUM STUMP. THERE WAS POOR STAPLE FORMATION. THE HANDLE WAS FULLY SQUEEZED, THERE WAS NO EXCESSIVE TISSUE INCORPORATED IN THE BARREL, THE INSTRUMENT WAS NOT IMPROPERLY MATCHED, AND THE DONUTS WERE COMPLETE. THE ANVIL COULD BE TILTED AFTER FIRING, THE ANVIL WAS NOT BENT, AND THE STAPLER SIZERS WERE USED. A LEAK TEST WAS PERFORMED USING A COLOSCOPE AND INTER-OPERATIVELY THE STAPLE LINE LOOKED NICE. AN ANASTOMOTIC LEAK OCCURRED THREE DAYS POST OPERATIVELY AND REQUIRED RE-INTERVENTION. THERE WAS TEMPORARY INJURY AS THE LEAK NEEDED TO BE FIXED. THERE WAS TISSUE DAMAGE AS THE LEAK WAS OVER SEWN. THE EVENT LEAD TO OR EXTENDED THE PATIENTS HOSPITALIZATION TIME BY TWO DAYS. THERE WAS NO REPORTED PATIENT INJURY.