GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS FELL OUT OF THE WING JAW ASSEMBLY OF A 2.5MM COUPLER. THIS WAS OBSERVED AFTER THE PRODUCT PACKAGE WAS OPENED, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: THE LOT # AND EXPIRATION DATE WERE NOT INCLUDED IN THE UDI # AS THE LOT WAS NOT RECOGNIZED IN THE SYSTEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3, H4, H6, H11. H11: TWO DEVICES WERE RECEIVED FOR EVALUATION. THE FIRST JAW ASSEMBLY WAS REVIEWED FOR THE REPORTED PROBLEM CODE OF ¿RING DISLODGEMENT¿. THE RIGHT RING OF THE 2.5MM COUPLER JAW ASSEMBLY WAS NO LONGER SEATED IN THE JAW ASSEMBLY WHICH WOULD INDICATE THAT THE RING HAD DISLODGED FROM THE JAW ASSEMBLY. THERE WERE NO SIGNS OF USE ON THE REMAINING COUPLER RING (DRIED BLOOD/TISSUE) WHICH WOULD INDICATE THAT THE ALLEGED EVENT OCCURRED PRIOR TO USE IN A SURGICAL PROCESS. THE REPORTED CONDITION WAS VERIFIED. 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.