MalfunctionFMC
NS-3631 N-STER DISPOSABLE
Received Nov 23, 2016
Report 9612030-2016-00710 · MDR key 6124561
Device
Product problems
- Crack
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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 AN ISSUE OCCURRED WITH LITE GLOVES. THE CUSTOMER REPORTS MULTIPLE COMPLAINTS HAVE BEEN RECEIVED INDICATING THAT THE COVIDIEN LIGHT HANDLE COVERS ARE CRACKING AND SPLITTING.