COUPLER

Additional Manufacturer Narrative

B5: UPDATE REFERENCE FROM "1.5 MM COUPLER" TO "3.0MM COUPLER". H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND THE RIGHT RING OF THE COUPLER WAS NO LONGER SEATED IN THE JAW ASSEMBLY; THE RING WAS RETURNED IN THE INNER TRAY FROM THE COUPLER PRODUCT. THIS WOULD INDICATE THAT THE RING HAD DISLODGED FROM THE JAW ASSEMBLY. THERE WAS NO OBSERVED DAMAGE TO THE JAW ASSEMBLY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A 1.5 MM COUPLER RING FELL OFF FROM THE DEVICE HOLDER BEFORE ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.