CYTOSURG

Description of Event or Problem

ACCORDING TO THE REPORTER, "OUR CUSTOMER EXPRESSED DIFFICULTY PASSING THROUGH THE TISSUE MORE THAN ONE TIME AND NEEDED TO OPEN ANOTHER SUTURE STATING THE NEEDLE WAS DULL. THERE ARE NO REMAINING SUTURES FORM THE COMPLAINT BOX/LOT AVAILABLE FOR RETURN AND THERE IS NO REPORT OF PATIENT HARM OR ADVERSE EVENT."

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED. THREE RETAIN SAMPLES FROM THE SAME LOT WERE TESTED. FOUR STITCHES WERE MADE WITH EACH NEEDLE. DURING THE TEST, NO DIFFICULTIES WERE NOTED IN USING THE SUTURE OR NEEDLES; THEY EXHIBITED NORMAL BEHAVIOR. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE REPORT COULD NOT SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY FDA.