3611 LITE GLOVE

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. 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 STATES THAT IT CRACKS IN THE FOLDS WHEN YOU TRY TO PUT IT ON THE HANDLE.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE INVESTIGATION DETERMINED THAT THE ISSUE IS MOST LIKELY CAUSED BY PROCESS VARIABILITY AND DIMENSIONAL TOLERANCE THAT MAY LEAD TO RARE INCIDENCES OF THE LIGHT GLOVE SPLITTING UPON APPLICATION TO THE DEVON¿ LIGHT HANDLE ADAPTER. THE DIMENSIONAL TOLERANCE ISSUE WAS RELATED TO A SLIGHT REDUCTION OF THE INSIDE DIAMETER OF THE HANDLE COVER. THIS REDUCTION IN DIAMETER WAS IMPLEMENTED TO ELIMINATE PLEATS IN THE GLOVE AND MINIMIZE THE POTENTIAL FOR SPLITS AND TEARS. CORRECTIVE ACTIONS: A CAPA WAS INITIATED, A ROOT CAUSE WAS DETERMINED, AND CORRECTIVE ACTION TAKEN. PROCESS MODIFICATIONS WERE MADE TO ADDRESS THE DIMENSIONAL TOLERANCE AND REDUCE DIFFICULTY DURING APPLICATION, WHILE MAINTAINING A DESIGN THAT IS FREE OF PLEATS. THIS MODIFICATION HAS ALREADY BEEN IMPLEMENTED. TO MITIGATE FURTHER OCCURRENCES, ADDITIONAL PROCESS IMPROVEMENTS WERE IMPLEMENTED AND INCLUDE UPDATES TO BOTH EQUIPMENT AND INSPECTION CRITERIA. AS AN ADDITIONAL MITIGATION STEP, THE PRODUCT LABELING HAS BEEN UPDATED INSTRUCTING THE USER TO INSPECT THE LIGHT GLOVE FOR BARRIER INTEGRITY AFTER APPLICATION TO THE LIGHT HANDLE. ALONG WITH THIS LABELING UPDATE, MEDTRONIC INITIATED A FIELD SAFETY NOTIFICATION IN OCTOBER 2016 NOTIFYING OUR CUSTOMERS OF LABELING UPDATE. ALTHOUGH THE PRODUCT MET SPECIFICATIONS AND ACCEPTABLE PRODUCTION QUALITY LIMITS MEDTRONIC RECOGNIZED THE OPPORTUNITY TO FURTHER REDUCE RISK BY CONDUCTING THE FSN AND UPDATING THE INSTRUCTIONS FOR USE.