NS-3600-B LITE GLOVE 1000/CASE
Received May 17, 2016
Report 9612030-2016-00228 · MDR key 5660972
Device
Product problems
- Torn Material
Patient
Not reported
- No Information
- No Information
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 05/05/2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT THE LIGHT HANDLE COVER IS TORN AND COULD NOT BE USED.
Additional Manufacturer Narrative
SUBMIT DATE: 07/19/2016. 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. SAMPLE ANALYSIS WAS PERFORMED USING THE PICTURES PROVIDED BY THE CUSTOMER, THE REPORTED ISSUE WAS CONFIRMED; THE PICTURES SHOW THE LITE GLOVE RIPPED ON THE SECTION OF THE HANDLE. 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.