GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO B5, H6 AND H11. B5: UPON ADDITIONAL INFORMATION, THE EVENT OCCURRED INTRAOPERATIVELY WHILE THE PATIENT WAS CONNECTED TO THE DEVICE. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE "NEEDLE HOLES" OF A 3.0MM COUPLER WERE MISALIGNED RESULTING IN A FAILED ANASTOMOSIS. THIS WAS OBSERVED DURING PRE-OPERATION SET UP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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