COUPLER

Additional Manufacturer Narrative

H10: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO OBSERVED DAMAGE. THE 3.0MM JAW ASSEMBLY WITH ONE RING INTACT WAS RETURNED IN THE INNER TRAY FROM THE COUPLER PRODUCT. THE RIGHT RING OF THE 3.0MM COUPLER WAS NO LONGER SEATED IN THE JAW ASSEMBLY. THIS WOULD INDICATE THAT THE RING HAD DISLODGED FROM THE 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE ANASTOMOSIS RING ON THE RIGHT SIDE OF A 3.0MM COUPLER FELL OFF WHEN THE OPERATOR REMOVED THE PROTECTIVE COVER FROM THE ANASTOMOSIS. THE FALLEN RING COULD NOT BE FOUND. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.