MalfunctionFMC
3612 LITE GLOVE
Received Sep 30, 2016
Report 9612030-2016-00480 · MDR key 5990468
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
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 STATES THAT THE LITE GLOVE RIPPED DURING USE. THEY REPLACED THE LITE GLOVE AS A RESULT. THIS HAPPENED WITH THREE GLOVES ALL DURING THE SAME CASE. THE FACILITY WAS USING SKYTRON LITE HANDLE WITH THE LITE GLOVE.