GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

B5: UPDATE "SEALING" TO "SEATING". UPDATE "APPLICATORY" TO "APPLICATOR (ANASTOMOSIS INSTRUMENT)". UPDATE "THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT." TO "THERE WAS NO PATIENT INVOLVEMENT." 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. HOWEVER, IF THE DEVICE WAS UNABLE TO LOAD, THE USER WOULD BE UNABLE TO USE THE COUPLER. THE USER WOULD DETECT THIS ISSUE DURING PRODUCT SET-UP PRIOR TO PATIENT USE. THE USER WOULD HAVE THE OPTION TO USE A NEW DEVICE. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, THERE WOULD BE NO ADVERSE HEALTH CONSEQUENCE REASONABLY EXPECTED TO RESULT FROM THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A 3.0MM MICROVASCULAR ANASTOMOTIC COUPLER DEVICE WAS FAULTY. THE COUPLER WAS NOT SEALING WELL IN THE APPLICATORY AND WAS LOOSE. THIS OCCURRED DURING USE OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.