MalfunctionFMC
3612 LITE GLOVE
Received Dec 7, 2016
Report 9612030-2016-00784 · MDR key 6151162
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
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 11/23/2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LITE GLOVE TORE DURING SET UP WHEN PULLING OVER DEVON LITE HANDLE, NO PATIENT PRESENT.