3612 LITE GLOVE

Additional Manufacturer Narrative

SUBMIT DATE: 08/24/2016. 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 REPORTS THE LITE HANDLE COVERS ARE SPLITTING ALONG THE SIDE THAT SLIDES OVER THE HANDLE. THE LIGHT GLOVE IS NOT TOO TIGHT. THE CUSTOMER FURTHER REPORTS THAT THE PLASTIC IS VERY THIN. THE SPLIT WAS DISCOVERED DURING STERILE SET UP AND THE SURGEON IS IN THE ROOM. THE PATIENT IS ON THE TABLE DRAPED. IF THE LIGHT HANDLE BECOMES CONTAMINATED DURING THE CASE AND IS CHANGED, THERE HAS BEEN SPLITTING OF THE NEWLY PLACED LIGHT HANDLE COVER AT THIS TIME. THE GLOVE IS REPLACED ONCE THE TEAR IS DISCOVERED AND REPLACED WITH THE STRONGER SUBSTITUTE LITE HANDLE COVER. O.R. LIGHTS USED ARE (B)(6). THERE IS NO ADDITIONAL ANTIBIOTICS GIVEN TO THE PATIENT WHEN THE LIGHT HANDLE COVERS SPLIT.

Additional Manufacturer Narrative

SUBMIT DATE: 11/16/2016. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED OR DATE OF MANUFACTURE IDENTIFIED AS THE LOT NUMBER WAS NOT PROVIDED. ALL DHR¿S ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR DISTRIBUTION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A THOROUGH FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND ROOT CAUSE ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. WHEN ROOT CAUSE(S) IS DETERMINED THE APPROPRIATE ACTIONS WILL BE TAKEN TO ADDRESS THE REPORTED CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.