GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6. 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.

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 2.0MM COUPLER WOULD NOT CLOSE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE COUPLER WAS CONNECTED TO THE ANASTOMOTIC INSTRUMENT AND VEIN WAS 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.