PREMIUM MF TA* 30-V3 TITANIUM STAPLER

Additional Manufacturer Narrative

(B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ELEVEN DEVICES. ONE INSTRUMENT WAS RECEIVED OPEN, LOADED WITH A FULLY FIRED SULU. THE REMAINING TEN INSTRUMENTS WERE RECEIVED SEALED IN THE BLISTER PACKAGES. ALL ELEVEN INSTRUMENTS WERE RECEIVED WITH THE JAWS OPEN. THE INSTRUMENT RECEIVED OPEN WAS 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. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

Additional Manufacturer Narrative

MANUFACTURER REFERENCE NUMBER: (B)(4).

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, THE JAWS WOULD NOT OPEN AND THE DEVICE HAD TO BE CUT OUT ON THE PORTAL VEIN. RESULTED IN SMALLER MARGINS. THE PRODUCT WAS NOT RE-STERILIZED PRIOR TO THIS INCIDENT. THE COMPLAINT PRODUCT WAS USED ON A PATIENT. THERE WAS UNANTICIPATED TISSUE LOSS DUE TO THE DEVICE HAVING TO BE CUT OFF TISSUE. RESULTED IN SMALLER MARGIN IN PORTAL VEIN FOR TRANSPLANT.