MalfunctionFMC
3611 LITE GLOVE
Received Dec 5, 2016 · Event occurred Oct 27, 2016
Report 1282497-2016-00956 · MDR key 6144351
Device
Product problems
- Device Disinfection Or Sterilization Issue
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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 AN ISSUE OCCURRED WITH LITE GLOVE.THE CUSTOMER REPORTS THE HANDLE SPLIT. THERE WAS NO STERILITY BARRIER ANYMORE. THERE WAS NO HARM TO THE PATIENT.