MalfunctionFMC
3611 LITE GLOVE
Received Dec 9, 2016 · Event occurred Dec 1, 2016
Report 9612030-2016-00802 · MDR key 6158629
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 WHILE PLACING THE LITE GLOVE ON THE HANDLE ADAPTER, IT SPLIT AND THE INTERN SURGEON LOST HIS STERILIZATION. AS A RESULT, THE SURGEON HAD TO USE NEW GLOVES.