COUPLER

Additional Manufacturer Narrative

H10: PORTIONS OF THE DEVICE WERE RECEIVED FOR EVALUATION. ONE COUPLER RING AND THE JAW ASSEMBLY WERE RETURNED IN A ZIPLOC BAG; BOTH ITEMS SHOWED SIGNS OF USE (DRIED BLOOD/TISSUE). THE COUPLER PINS OF THE RETURNED RING HAD PIERCED THE BAG AND THE COUPLER WAS STUCK TO THE PLASTIC BAG. THE COUPLER PIN WAS FOUND TO HAVE A BENT PIN WHICH COULD HAVE OCCURRED DURING SHIPMENT SINCE THE COUPLER RING HAD PIERCED THE ZIPLOC BAG. WITH THE ONE RING NO LONGER IN THE JAW ASSEMBLY AND THE OTHER RING NOT RETURNED FOR INVESTIGATION, IT WAS SHOWN THAT THE RINGS HAD BEEN DISLODGED FROM THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED, HOWEVER, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RIGHT RING OF A 2.5MM COUPLER WAS OUT OF THE SUPPORT/CARRIER. THE EVENT OCCURRED WHEN CLOSING THE COUPLER DURING A SURGICAL PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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