3612 LITE GLOVE
Received Sep 5, 2016
Report 9612030-2016-00419 · MDR key 5927765
Device
Product problems
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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 09/01/2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. CUSTOMER REPORTS THAT WHEN THE GLOVES ARE PULLED OVER THE ADAPTER, IT IS TOO TIGHT AND TEARS APART. THE CUSTOMER FURTHER STATED THAT THE SPLIT WAS FOUND DURING SETUP AND A NEW GLOVE WAS PLACED. THERE WAS NO PATIENT IN ROOM.
Additional Manufacturer Narrative
SUBMIT DATE: 11/16/2016. 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. 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.