ENDO GIA

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC COMPLETE STOMACH RESECTION FOR CANCER, WHILE ON ANASTOMOSIS, THERE WAS INCORRECT B STAPLE FORMATION IN ALL 12 RELOADS THAT WERE USED; SOME WERE NOT PROPERLY FORMED, AND SOME STAPLES WERE OPENED. THIS CAUSES THE PATIENT TO HAVE TISSUE BLEEDING AND EVEN SPILL BOWEL CONTENTS INTO THE ABDOMINAL CAVITY. THE STAPLE LINE WAS INCOMPLETE DISTALLY AND HAD TO BE REINFORCED WITH A SUTURE TO FIX THE STAPLE LINE AND RESOLVE THE ISSUE. IT WAS NOTED THAT THE STAPLES THAT FELL OFF IN THE CAVITY AND THAT WERE LEFT OPEN WERE REMOVED.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X) ; 030458, 030458 ENDO GIA R/OR 60 3.5MM (LOT#:T2B123X). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.