PREMIUM MF TA* 30-V3 TITANIUM STAPLER

Additional Manufacturer Narrative

(B)(4). USER FACILITY LISTED IN INITIAL REPORTER.

Description of Event or Problem

ACCORDING TO THE REPORTER: OCCURRED DURING A LIVER TRANSPLANT PROCEDURE. THE JAWS WOULD NOT OPEN AND THE DEVICE HAD TO BE CUT OUT ON THE PORTAL VEIN. RESULTED IN SMALLER MARGINS OF THE PORTAL VEIN FOR TRANSPLANT, TISSUE LOSS. AFTER THE PROCEDURE, THE DEVICE WAS ABLE TO BE OPENED, BUT THE BUTTON WAS JAMMED.

Additional Manufacturer Narrative

FTR#(B)(4). UDI#(B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE STAPLERS. THE INSTRUMENTS WERE RECEIVED OPEN; EACH LOADED WITH A FULLY FIRED 2.5MM SULU. A PIECE OF TISSUE WAS OBSERVED STUCK TO THE ANVIL OF ONE INSTRUMENT. THE STAPLES IN THE TISSUE WERE PROPERLY FORMED. THE CARTRIDGES WERE RELOADED WITH STAPLES. THE INSTRUMENTS AND SULUS WERE APPLIED TO APPROPRIATE TEST MEDIA WITH PROPER STAPLE FORMATION. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT, AS RECEIVED, MET SPECIFICATIONS. PRODUCT ANALYSIS INDICATES THAT THE DEVICES WERE USED IN A SURGICAL PROCEDURE. 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 PRODUCT ANALYSIS CONCLUDED THERE WERE NO DEVICE ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE TISSUE ATTACHED TO THE ANVIL, INDICATED THAT THE INSTRUMENT WAS NOT PROPERLY USED DURING THE PROCEDURE. HOWEVER THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHAT IMPROPER USE OCCURRED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.