GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT THE PINS OF A MICROVASCULAR ANASTOMOTIC COUPLER DEVICE WERE NOT ENGAGING THE OPPOSING HOLES WHEN CLOSING. THIS ISSUE OCCURRED DURING USE OF THE DEVICE INTRA-OP. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, E1 ADDRESS, E3, H4, H6 (UPDATE CODES), H11. CORRECTION: D4 MODEL #, G4: PMA/510K #. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE AND A PHOTOGRAPH OF THE ACTUAL SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF PHOTO SAMPLE SHOWED THAT THE COUPLER RINGS WERE MISALIGNED WHEN BROUGHT TOGETHER. THE MISALIGNMENT WAS VISIBLE WHICH WOULD NOT ALLOW THE PROCESS TO BE COMPLETED SUCCESSFULLY AS THE RINGS WOULD NOT BE APPROPRIATELY APPROXIMATED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. VISUAL INSPECTION WAS PERFORMED ON THE COMPANION SAMPLE IDENTIFIED THE COUPLER RECEIVED FULLY SEATED IN THE PACKAGING. THE COUPLER WAS FUNCTIONALLY TESTED BY CLICKING THE JAW ASSEMBLY INTO THE ANASTOMOTIC INSTRUMENT (AI) AND BROUGHT TOGETHER BY ROTATING THE AI KNOB TO MIMIC THE USE IN A SURGICAL PROCESS. THE RINGS ALIGNED AS INTENDED WHEN APPROXIMATED AND WERE ABLE TO BE PUSHED OUT OF THE JAWS UPON APPROXIMATION. THE SAMPLE MET DEVICE SPECIFICATIONS. THE REPORTED CONDITION WAS NOT VERIFIED ON THE COMPANION SAMPLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.