PREMIUM MULTIFIRE TA

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE INSTRUMENT WAS RECEIVED DISASSEMBLED AND DAMAGED. THE LOADING UNIT WAS FULLY APPLIED. FOUR PROPERLY FORMED STAPLES WERE RECEIVED. THE CONDITION OF THE INSTRUMENT PRECLUDES FUNCTIONAL EVALUATION. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS NOT IDENTIFIED DUE TO THE AMOUNT OF DAMAGE TO THE RECEIVED DEVICE; HOWEVER, THE MANNER IN WHICH THIS FAILURE OCCURRED COULD NOT BE RELIABLY DETERMINED WITH THE INFORMATION AVAILABLE. 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.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

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 AN OPEN THORACOSCOPIC LOBECTOMY PROCEDURE WHEN THE DEVICE APPLIED ON VESSEL, THE DEVICE WAS DIFFICULT/UNABLE TO OPEN. THE DEVICE WOULD NOT OPEN AFTER CLAMPED OVER THE TISSUE. IT WAS REMOVED USING ADDITIONAL TOOL. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE SURGEON TOOK THE INSTRUMENT APART IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THERE WAS NO PATIENT INJURY.