GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

CORRECTION TO E1: INITIAL REPORTER E-MAIL (UPDATE); REMOVE "E1: INITIAL REPORTER E-MAIL: (B)(6) FROM H11. ADDITIONAL INFORMATION: D4 (EXPIRATION DATE, UDI), H4, H6(UPDATE CODES), H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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) E1: INITIAL REPORTER (B)(6) SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RING OF A GEM COUPLER,4.0MM BECAME DETACHED. THIS OCCURRED DURING THE VENOUS ANASTOMOSIS IN THE MICROSURGERY PHASE. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.