MalfunctionFMC
3611 LITE GLOVE
Received Dec 20, 2016 · Event occurred Dec 8, 2016
Report 9612030-2016-00836 · MDR key 6190280
Device
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 12/20/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 12/12/2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE DEVICE HAD A HOLE DURING SET UP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.