EB040, OPEN FUSION DEVICE, 6/BX

Additional Manufacturer Narrative

UPDATE CUSTOMER'S ADDRESS. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING NOTED THAT THE JAWS OF THE DEVICE WERE SLIGHTLY MISALIGNED. THE BLADE LEVER WAS ACTIVATED AND ENGINEERING CONFIRMED THAT THE BLADE WAS DIFFICULT TO ACTUATE. THE JAWS WERE STRAIGHTENED AND THE BLADE WAS ABLE TO ACTUATE SMOOTHLY. THE ROOT CAUSE OF THE INCIDENT IS DUE TO VARIATIONS IN THE WELDING PROCESS DURING MANUFACTURING AND ASSEMBLY, WHICH CAN CAUSE THE JAWS TO BECOME SLIGHTLY MISALIGNED. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS A RESULT OF THIS FEEDBACK, ADDITIONAL PROCESS AND INSPECTION STEPS HAVE BEEN ADDED TO THE MANUFACTURING PROCESS TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

Additional Manufacturer Narrative

RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

Description of Event or Problem

GASTRECTOMY- "AFTER ONLY A FEW SEALS, BLADE TRIGGER STARTED STICKING AND NOT SPRINGING BACK TO POSITION. HAND WAS LATCHED. SURGEON DID NOT FEEL SAFE MOVING FORWARD AND ASKED FOR ANOTHER DEVICE. REP MENTIONED THAT SURGEON MAY HAVE TRIED TO DEPLOY THE BLADE WHILE THE JAWS WERE STILL OPEN. SECOND DEVICE (CT512) SHOWED SLIGHT STICKING OF BLADE TRIGGER ONCE OR TWICE DURING CASE SO THAT IS BEING CERED AS WELL."