PREMIUM MULTIFIRE TA

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, DURING A LEFT PNEUMONECTOMY, WHILE THEY USED THE DEVICE ON THE SUPERIOR PULMONARY VEIN WITHOUT ANY PROBLEM, THEY PROCEEDED TO APPLY THE INSTRUMENT ON THE SECOND LEFT PULMONARY VEIN & ACTIVATED THE INSTRUMENT. WHEN THEY WANTED TO OPEN IT, THE INSTRUMENT REMAINED CLOSE ON THE VEIN. THEY HAD TO DISSECT THE VEIN TOWARD THE MEDIASTINUM TO APPLY A NEW INSTRUMENT WITHOUT ANY PROBLEM. THEY WERE THE ABLE TO TAKE THE INSTRUMENT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER THAT. THE INSTRUMENT BEING RETURNED WILL BE IN THE CLOSE POSITION WITH THE VEIN SEGMENT IN IT.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE INSTRUMENT WAS RECEIVED FULLY APPLIED. THE JAW WAS OPEN, TISSUE WAS OBSERVED IN THE JAW WITH A FULL COMPLEMENT OF STAPLES PRESENT. FUNCTIONALLY; THE DEVICE LOADING UNIT(DLU) WAS RESET. THE JAW CLOSES SMOOTHLY. THE PIN SLIDE ADVANCES FULLY. THE JAW OPENS WHEN OPEN BUTTON IS DEPRESSED. THE INSTRUMENT AND DLU WERE CYCLED WITH ACCEPTABLE RESULTS. NO FUNCTIONAL ABNORMALITIES WERE OBSERVED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LEFT PNEUMONECTOMY, WHILE THEY USED THE DEVICE ON THE SUPERIOR PULMONARY VEIN WITHOUT ANY PROBLEM, THEY PROCEEDED TO APPLY THE INSTRUMENT ON THE SECOND LEFT PULMONARY VEIN <(>&<)> ACTIVATED THE INSTRUMENT. WHEN THEY WANTED TO OPEN IT, THE INSTRUMENT REMAINED CLOSE ON THE VEIN. THEY HAD TO DISSECT THE VEIN TOWARD THE MEDIASTINUM TO APPLY A NEW INSTRUMENT WITHOUT ANY PROBLEM. THEY WERE THE ABLE TO TAKE THE INSTRUMENT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER THAT. THE INSTRUMENT BEING RETURNED WILL BE IN THE CLOSE POSITION WITH THE VEIN SEGMENT IN IT. THERE WAS NO PATIENT INJURY.