MalfunctionFMC
3612 LITE GLOVE
Received Aug 24, 2016
Report 9612030-2016-00394 · MDR key 5900866
Device
Product problems
- Contamination
- Split
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 REPORTS THE LIGHT HANDLE COVER SPLIT AND CONTAMINATED THE SURGEON'S GLOVE.