GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT A 2.5MM COUPLER DISASSOCIATED FROM THE APPLIER. THIS OCCURRED PRIOR TO PATIENT USE. TO RESOLVE THIS ISSUE, ANOTHER COUPLER WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED THE LEFT RING OF THE COUPLER NO LONGER SEATED IN THE JAW ASSEMBLY WHICH WOULD INDICATE THAT THE RING HAD DISLODGED FROM THE JAW ASSEMBLY. THERE WAS NO OBSERVED DAMAGE TO THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.