Description of Event or Problem · 0
THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE THE ANALYSIS OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED, AS IT WAS NOT RETURNED TO ASHITAKA FACTORY. CONCERNING THE NOVEMBER-2020 PRODUCTION (0YK) LOT, REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD CONFIRMED THAT THERE WAS NO PROBLEM IN THEM. CONCERNING THE NOVEMBER-2020 PRODUCTION (0YK) LOT, REVIEW OF THE COMPLAINT RECORD FOUND NO OTHER SIMILAR REPORTS FROM OTHER FACILITIES. ASHITAKA FACTORY ASSURES THE QUALITY OF THIS PRODUCT BY CONDUCTING THOROUGH INSPECTIONS, INCLUDING THE FOLLOWINGS, IN THE PRODUCTION PROCESS. 100% VISUAL INSPECTION IS PERFORMED BEFORE THE PACKAGING PROCESS FOR ANY ANOMALY SUCH AS SCRATCHED IN ITS APPEARANCE. THE OUTER DIAMETER OF THE CORE WIRE IS CONTROLLED TO ASSURE ITS STRENGTH. 100% VISUAL INSPECTION IS PERFORMED IN THE PRODUCT ASSEMBLY PROCESS TO ENSURE THAT THERE ARE NO SCRATCHES OR EXPOSED WIRES. THE CONDITIONS (COATING SPEED, DIPPING TIME) AT THE TIME OF APPLYING THE HYDROPHILIC COAT ARE CONTROLLED. AS A PART OF THE SHIPPING INSPECTIONS, SAMPLING-BASED MEASUREMENT OF THE SURFACE SLIDABILITY AND THE STRENGTH OF THE TIP SECTION AGAINST TENSILE LOAD ARE PERFORMED. A REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE DESCRIPTION OF THE EVENT AND THE INVESTIGATION RESULT, IT WAS ASSUMABLE THAT THE ACTUAL SAMPLE WAS MANIPULATED WHILE THE DISTAL END OF THE CONCURRENTLY USED METAL NEEDLE WAS IN CONTACT WITH THE URETHANE COAT SURFACE OF THE ACTUAL SAMPLE, WHICH RESULTED IN THE PEELING OF URETHANE COAT. HOWEVER, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE DETERMINED SINCE THE CONFIRMATION OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED. PLEASE SEE MDR 2243441-2021-00057 FOR THE IMPORTER REPORT. (B)(4).