GEM FLOW COUPLER

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS OF A 3.0MM FLOW COUPLER WERE MISALIGNED DURING A VENOUS ANASTOMOSIS PROCEDURE ON A PATIENT. THE RINGS DID CLOSE; HOWEVER, THE "PRONGS DID NOT MATCH UP PROPERLY FROM ONE SIDE OF THE JAW ASSEMBLY TO THE OTHER RECIPROCAL SIDE RECEIVER". THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, THE DEVICE WAS EXPLANTED AND REPLACED TO REDO THE ANASTOMOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: 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.