GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 AND H11: H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND A BENT PIN ON THE RIGHT RING OF THE JAW ASSEMBLY WAS OBSERVED. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6, AND H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. NO SIGNS OF USE WERE VISIBLE ON THE COUPLER RINGS, WHICH IS CONSISTENT WITH THE COMPLAINTS STATEMENT THAT THE ALLEGED EVENT OCCURRED PRIOR TO USE. DURING INVESTIGATION IT WAS OBSERVED THAT THE RIGHT COUPLER RING THAT WAS NO LONGER SEATED IN THE JAW ASSEMBLY HAS FIVE BENT PINS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE STEEL NEEDLE (PIN) OF A 3.5MM COUPLER WAS "CROOKED". THIS WAS NOTICED AFTER THE ANASTOMOSIS RING WAS INSTALLED AND VISUALLY INSPECTED UNDER THE MICROSCOPE. 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.