MalfunctionFMC
3612 LITE GLOVE
Received Oct 10, 2016 · Event occurred Oct 4, 2016
Report 9612030-2016-00509 · MDR key 6015624
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
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 (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THE OPERATING ROOM STAFF OPENED THE BAG AND THERE WAS A BROKEN LITE GLOVE FOUND. NO PATIENT INVOLVED.