3612 LITE GLOVE

Additional Manufacturer Narrative

SUBMIT DATE: 11/22/2016. 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 THE LITE GLOVE SPLIT IN TWO DURING A PROCEDURE AND FELL INTO THE SURGICAL FIELD. THE SPLIT DOWN THE MIDDLE WAS NOT NOTICED WHEN THE LITE GLOVE WAS PLACED ON THE LITE HANDLE. THIS WAS NOTICED WHEN THE LITE GLOVE FELL INTO THE FIELD. THE SURGICAL FIELD WAS CONTAMINATED AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS AS A RESULT.

Additional Manufacturer Narrative

COMPLAINTS HAVE BEEN RECEIVED BY MEDTRONIC STATING THE DEVON LIGHT GLOVE SPLITS/TEARS AFTER APPLICATION TO THE SURGICAL LIGHT. THE COMPLAINTS INVOLVE LOTS MANUFACTURED MAY 2015 TO CURRENT. CAPA (B)(4) WAS OPENED JANUARY 2016 TO ADDRESS A SMALL ((B)(4)) POPULATION OF COMPLAINTS THAT WERE ALLEGEDLY ¿TOO TIGHT¿. THE CONDITION PRESENTED A CHALLENGE TO THE USER AS THE GLOVE WAS TOO TIGHT DURING THE INSTALLATION ONTO THE LIGHT HANDLE, MAKING THE INSTALLATION DIFFICULT TO IMPOSSIBLE, WITH THE POTENTIAL FOR TEARS. A MULTIFUNCTIONAL TEAM REVIEWED THE COMPLAINTS AND FAILURE MODES AS PART THE CAPA INVESTIGATION. AN ISHIKAWA DIAGRAM WAS COMPLETED FOCUSING ON THE POTENTIAL CAUSES THAT COULD ORIGINATE THE REPORTED CONDITIONS. THE INVESTIGATION DETERMINED THAT WHILE THE PRODUCT MET SPECIFICATION AND THE OBSERVED COMPLAINT RATE WAS BELOW THE DMR REQUIREMENTS, PROCESS VARIATION COMBINED WITH THE DIMENSIONAL TOLERANCE BETWEEN THE INNER DIAMETER OF THE GLOVE AND THE CORRESPONDING HANDLE COULD LEAD TO APPLICATION FORCES THAT SPLIT THE LIGHT GLOVE DURING APPLICATION ONTO THE ASSOCIATED LIGHT HANDLE. THE DIMENSIONAL TOLERANCE WAS RELATED TO A SLIGHT REDUCTION OF THE INSIDE DIAMETER OF THE HANDLE COVER. THIS REDUCTION IN DIAMETER WAS IMPLEMENTED, ALONG WITH OTHER FACTORS, TO ELIMINATE PLEATS IN THE GLOVE AND MINIMIZE THE POTENTIAL FOR SPLITS AND TEARS. THIS RESULTED IN A SMALL NUMBER OF LIGHT GLOVES THAT FIT TIGHTLY AND OR SPLIT WHEN APPLIED TO THE LIGHT HANDLE. IN JUNE 2016, THE CORRECTIVE ACTION WAS IMPLEMENTED THROUGH PROCESS MODIFICATIONS THAT INCLUDED UPDATES TO BOTH EQUIPMENT AND INSPECTION CRITERIA WHEREBY INSERTION FORCE WAS NOW MEASURED ON THE LINE. ADDITIONALLY, A FIELD SAFETY NOTICE COMMUNICATING AN UPDATE TO THE IFU WAS ISSUED SEPTEMBER 29, 2016 TO FURTHER MITIGATE THE RISK OF A TOO TIGHT OR SPLIT CONDITION. IN OCTOBER 2016, POST IMPLEMENTATION OF THE ABOVE CORRECTIVE ACTIONS, COMPLAINTS WERE RECEIVED REPORTING THE PRODUCT IS SPLIT IN THE PACKAGE, THE PRODUCT SPLIT/TORE DURING APPLICATION OR A SPLIT WAS DISCOVERED DURING OR POST PATIENT PROCEDURE. AS SUCH, CAPA (B)(4) WAS OPENED TO DOCUMENT THE INVESTIGATION AND ACTIONS TAKEN. THE INITIAL INVESTIGATION DETERMINED THAT WHILE THE PRODUCT MEETS SPECIFICATION AND THE OBSERVED COMPLAINT RATE IS BELOW THE DMR REQUIREMENTS, ADDITIONAL TESTING AND REVIEW IS NECESSARY TO TAKE CORRECTIVE ACTION TO FURTHER REDUCE RISK AS FAR AS POSSIBLE. ONGOING EFFORTS AT THIS TIME INCLUDE REVIEW OF THE MATERIAL, PROCESS PARAMETERS, AND DESIGN. FURTHER INVESTIGATION IS NECESSARY TO DETERMINE ROOT CAUSE OF THIS ISSUE. IN JAN 2017 MEDTRONIC CONDUCTED A RECALL OF ITS COVIDIEN DEVON¿ LIGHT GLOVES DISTRIBUTED AS SINGLE STERILE ITEMS AND IN SPECIFIC PROCEDURE KITS. ALL LOT NUMBERS OF DEVON¿ LIGHT GLOVE DEVICES WITHIN EXPIRY BEGINNING WITH LOT NUMBER 630XXXXXXX AND LOWER ARE AFFECTED BY THIS FIELD ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.