Description of Event or Problem · 0
THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICES WERE ANALYZED AND VISUAL INSPECTION REVEALED THAT INTERIOR STERILE PACKAGING WAS DAMAGED. HOWEVER, THE INSTRUMENTS WITHIN THE KIT WERE SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION, AND NO ANOMALIES OR DEFECTS COULD BE CONFIRMED. THEREFORE, THE PROBABLE CAUSE SELECTED IS CAUSE TRACED TO TRANSPORT/STORAGE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, STERILITY CAN ONLY BE ASSURED IF THE PACKAGE IS INTACT. DO NOT USE THIS DEVICE IF THE PACKAGE HAS BEEN OPENED OR DAMAGED. ONCE OPENED, DO NOT ATTEMPT TO REUSE OR RESTERILIZE THIS PRODUCT. STORE IN A SUITABLE, CLEAN AREA UNTIL READY FOR USE. USE STERILE PACKAGED SUPERION IDS INSTRUMENTS PRIOR TO THE EXPIRATION DATE LISTED ON THE PACKAGE" AS WELL AS "INSPECT STERILE PACKAGED SUPERION IDS INSTRUMENTS AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPPING AND HANDLING. DAMAGE TO DEVICES OR PACKAGING MAY INDICATE THE PRESENCE OF UNSAFE PRODUCT. IN THE EVENT OF DAMAGE TO THE STERILE PACKAGING, RETAIN THE PACKAGE WITH THE CONTENTS AND CONTACT BOSTON SCIENTIFIC NEUROMODULATION CORPORATION FOR REPLACEMENT" FINALLY "SUPERION IDS INSTRUMENTS SHOULD BE STORED IN A SUITABLE, CLEAN AREA PRIOR TO USE" IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.