7 MM ENDOSCOPE MAQUET CARDIOVASCULAR

MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON MARCH 1, 2010. THE VISUAL INSPECTION REVEALED THAT THERE WERE NO PHYSICAL NON-CONFORMITIES WITH THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED AND THE FINAL FAILURE ANALYSIS HAS BEEN RECEIVED. (B) (4)

THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE 7 MM ENDOSCOPE LENS WAS BECOMING LOOSE. THE CASE WAS COMPLETED BY CONVERSION TO OPEN LEG SURGERY. THE HOSPITAL DID NOT REPORT ANY ADDITIONAL PATIENT EFFECTS. THE PRODUCT WAS RETURNED.