MalfunctionFMC
NS-3631 N-STER DISPOSABLE
Received Nov 10, 2016
Report 9612030-2016-00611 · MDR key 6092637
Device
Product problems
- Break
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 A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THE LIGHT HANDLE COVERS ARE BROKEN, SPLITTING AND CRACKING.