NS-3631 N-STER DISPOSABLE

Additional Manufacturer Narrative

THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. ONE PICTURE WAS PROVIDED FOR EVALUATION AND THE REPORTED CONDITION WAS CONFIRMED; THE PICTURE SHOWS THAT THE CONE OF THE LITE SLEEVE IS RIPPED. THE INVESTIGATION WAS PERFORMED ANALYZING THE PERFORMANCE OF THE MOLDS, MACHINE AND PROCESS. THE MOST LIKELY ROOT CAUSE INDICATES THAT THIS CONDITION COULD OCCUR DURING THE MOLDING PROCESS AS THESE PARTS COULD GET STUCK IN THE MOLD CAVITY (NEST) DUE TO SIMILAR COOLING TEMPERATURES FROM BOTH SIDES OF THE MOLD. THE PART GETS STUCK ON THE STATIONARY SIDE OF THE MOLD AND IN ORDER TO REMOVE THE STUCK PART, THE PART NEEDS TO BE CUT IN ORDER TO BREAK THE VACUUM BETWEEN THE PART AND MOLD. A CHANGE DEVELOPMENT PROCESS (CDP) TO VALIDATE AND ACHIEVE OPTIMAL PROCESS CONDITIONS (MOLD, MACHINE, AIR SYSTEM, ETC.) WAS IMPLEMENTED. THE VALIDATION WAS EXECUTED HOWEVER THE PRODUCTION SCHEDULE AND DOCUMENTATION PROCESS FOR THE IMPLEMENTATION WILL BE CONDUCTED DURING THE CDP CLOSURE. DURING THIS PERIOD NO MATERIAL WILL BE PRODUCED WITH THE MOLD.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTED THAT THE LIGHT HANDLE COVERS WERE CRACKED WHEN OPENED FOR USE.