MalfunctionFMC
3612 LITE GLOVE
Received Jan 31, 2017
Report 9612030-2017-00045 · MDR key 6291477
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: 01/28/2017. 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) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT THE LITE HANDLE TEARS ON THE HANDLE. THE ISSUE WAS DISCOVERED DURING THE PROCEDURE.