GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE ANASTOMOTIC INSTRUMENT OF A 2.5MM COUPLER WOULD NOT CLOSE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE COUPLER WAS CONNECTED TO THE ANASTOMOTIC INSTRUMENT AND VEIN ATTACHED HOWEVER THE INSTRUMENT WOULD NOT CLOSE WITH THE COUPLER ATTACHED". THIS OCCURRED DURING AN INTRA-OP PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H4, H6, AND H11: H11: A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.