GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ONLY THE RINGS OF THE DEVICE WERE RECEIVED FOR EVALUATION. THE RETURNED PRODUCT SHOWED SIGNS OF USE (DRIED BLOOD AND TISSUE) ON THE APPROXIMATED 3.0MM RINGS. VISUAL INSPECTION REVEALED A MISALIGNMENT BETWEEN THE RETURNED RINGS. THE MISALIGNMENT THAT IS VISIBLE WOULD NOT ALLOW THE PROCESS TO BE COMPLETED SUCCESSFULLY AS THE RINGS WOULD NOT BE APPROPRIATELY APPROXIMATED. IF THE COUPLER RING HAD BEEN PARTIALLY DISLODGED FROM THE JAW ASSEMBLY DURING THE PREPARATION FOR OR IN USE DURING THE SURGICAL PROCESS, A MISALIGNMENT IS POSSIBLE. THE JAW ASSEMBLIES WERE CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI). THE KNOB OF THE AI WAS THEN ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED IN A SURGICAL PROCESS. THERE WAS NO OBSERVED FUNCTIONAL MALFUNCTION WITH 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.

Description of Event or Problem

IT WAS REPORTED THAT A COUPLER HAD PINS ¿FALLING THROUGH¿. THIS WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.