MalfunctionFMC
3611 LITE GLOVE
Received Nov 22, 2016
Report 9612030-2016-00695 · MDR key 6122581
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 (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH LITE GLOVES. THE CUSTOMER REPORTS THAT DURING SET UP, EVERY OTHER LITE GLOVE TEARS APART WHILE PULLING OVER THE HANDLE. NO PATIENT PRESENT.