N
Patient 1
TO DATE, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, THIS COMPLAINT WILL BE REASSESSED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR HISTORICAL COMPLAINT REVIEW REVEALED (B)(4) PRIOR COMPLAINTS FOR THIS DEVICE FAMILY AND FAILURE MODE. IN THIS SAME TIMEFRAME, (B)(4) UNITS HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE, MAKING THE RATE OF OCCURRENCE OF THIS FAILURE (B)(4) PERCENT. A RISK ANALYSIS WAS PERFORMED AND DEEMED ACCEPTABLE. THIS REPORTED PACKAGING ISSUE WAS OBVIOUS TO THE DISTRIBUTOR, PROMPTING THE RETURN OF THE DEVICE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCT OCCURS MULTIPLE TIMES PRIOR TO USE. GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNING. IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY. THIS INCIDENT TYPE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.