MalfunctionFMC
NS-3631 N-STER DISPOSABLE
Received Nov 1, 2016
Report 9612030-2016-00589 · MDR key 6070528
Device
Product problems
- Crack
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 UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 10/12/2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT UPON ASSEMBLING ONE OF THEIR KITS THEY DISCOVERED A LIGHT HANDLE CRACKED AT THE BASE OF THE HANDLE.