COUPLER

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER CITY: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS OF A 2.5MM COUPLER FELL OFF FROM THE BASE. THIS WAS DISCOVERED DURING A VASCULAR ANASTOMOSIS PROCEDURE ON A PATIENT, WHEN CLOSING THE ANASTOMOTIC INSTRUMENT. A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR EVALUATION. THE 2.5MM COUPLER RINGS AND JAW ASSEMBLY WERE RETURNED, FREE FLOATING, IN THE COUPLER TRAY IN A ZIPLOC BAG. THE ALLEGATION OF RING DISLODGEMENT WILL BE CONSERVATIVELY CONFIRMED AS THE 2.5MM COUPLER RINGS THAT WERE RETURNED FOR INVESTIGATION WERE NO LONGER SEATED IN THE COUPLER JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.