MalfunctionFMC
3611 LITE GLOVE
Received Dec 21, 2016 · Event occurred Dec 1, 2016
Report 9612030-2016-00840 · MDR key 6193515
Device
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 12/21/2016. 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 A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT DURING SET UP, THE LITE GLOVE TORE OFF.