MalfunctionFMC
3612 LITE GLOVE
Received Oct 20, 2016
Report 9612030-2016-00539 · MDR key 6044699
Device
Product problems
- Torn Material
Patient
Not reported
- No Information
- No Information
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 10/13/16 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS DURING ORTHOPEDIC SURGERY THE LITE GLOVE WAS TORN. THE TEAR WAS REALIZED DURING THE PROCEDURE, AFTER THE LITE HANDLE WAS TOUCHED SEVERAL TIMES. A NEW GLOVE WAS USED AND THE PROCEDURE CONTINUED. A SMEAR WAS TAKEN FROM THE PATIENT.