MalfunctionFMC
3611 LITE GLOVE
Received Dec 7, 2016
Report 9612030-2016-00785 · MDR key 6151316
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 12/07/2016. 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 AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT WHILE INSPECTING THE GLOVES AFTER INSTALLING, THEY NOTICED THE LITE GLOVES WERE BROKEN. NEW ONES WERE USED. NO PATIENT INVOLVEMENT.