MalfunctionFMC
3612 LITE GLOVE
Received Aug 23, 2016
Report 9612030-2016-00385 · MDR key 5895955
Device
Product problems
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 08/23/2016. 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 REPORTS THAT THE LIGHT HANDLE COVER SPLIT AS THEY PUT IT ON. THE LIGHT HANDLE COVER WAS NOT TOO TIGHT. THE SPLIT WAS FOUND AFTER THE DOCTOR SCRUBBED IN AND A NEW GLOVE PLACED. A SKYTRON HANDLE WAS BEING USED WITH THE LITE GLOVE.