MalfunctionFMC
3611 LITE GLOVE
Received Nov 1, 2016
Report 9612030-2016-00584 · MDR key 6069173
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: 11/1/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; 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 REPORTS THAT WHILE INSERTING THE DEVICE, IT TORE OFF INTO TWO. ANOTHER DEVICE HAD TO BE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN THE ROOM WHEN THE TEAR OCCURRED, THERE WAS NO ANTIBIOTICS REQUIRED FOR THE PATIENT.