GIA 100-4.8 SINGLE USE LOADING UNIT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, WITH A SUCCESSFUL FIRST FIRING ATTEMPT, AN ADDITIONAL RELOAD BUT, ONCE, FIRED, THERE WAS STAPLE LINE BLEEDING WHERE THE STAPLES DID NOT FORM PROPERLY. HEMOSTASIS WAS ACHIEVED BY LIGATING WITH A MANUAL SUTURE. THERE WAS NO FURTHER EFFECT TO THE PATIENT REPORTED.

Additional Manufacturer Narrative

(B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE STAPLER OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE INSTRUMENT DISPLAYED NO ABNORMALITIES. FURTHER VISUAL INSPECTION OF THE CARTRIDGE NOTED THAT THE SINGLE USE LOADING UNIT (SULU) WAS FULLY APPLIED. ADDITIONALLY, MICROSCOPIC INSPECTION OF THE KNIFE BLADE DISPLAYED NO DAMAGE. THE SULU WAS RESET, RELOADED WITH STAPLES, AND RELOADED INTO THE INSTRUMENT. THE SULU AND INSTRUMENT WERE APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS; THE KNIFE CUT COMPLETELY AND CLEANLY AND THE STAPLE LINE WAS PROPERLY FORMED. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE FILE WILL BE CLOSED AS FIRED SATISFACTORILY AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AS NECESSARY. (B)(4).

Description of Event or Problem

ACCORDING TO THE REPORTER: TO FIX THE INCOMPLETE STAPLE LINE IT WAS OVER SEWED. THE LAST KNOWN PATIENT STATUS IS STABLE.