GEM FLOW COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H11: THE DEVICE WAS RETURNED FOR EVALUATION, FREE FLOATING IN THE FLOW COUPLER TRAY. VISUAL INSPECTION WAS PERFORMED WHICH SHOWED SIGNS OF USE AND THE RIGHT RING WAS NOTED TO BE DISLODGED FROM THE JAW ASSEMBLY. DURING THE FUNCTIONAL TESTING, THE JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED AND THE KNOB OF THE AI WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS; NO ISSUES WERE NOTED. HOWEVER, FURTHER INSPECTION IDENTIFIED THE PROBE OF THE FLOW COUPLER TO BE SEATED IMPROPERLY IN THE SCABBARD. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE ISSUE 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

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

Description of Event or Problem

IT WAS REPORTED THAT A FLOW COUPLER DISLODGED. WHEN TRYING TO PUSH THE VESSEL ONTO THE WHITE RING, THE RING CAME OFF THE DEVICE. TO RESOLVE THIS ISSUE, A NEW DEVICE WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.