MalfunctionFMC
3612 LITE GLOVE
Received Jan 3, 2017
Report 9612030-2017-00001 · MDR key 6219173
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
SUBMIT DATE: 01/03/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 12/14/2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT THE LITE GLOVE WAS PULLED OVER THE HANDLE PER INSTRUCTIONS FOR USE. AT THE END OF THE LUMBAR VERTEBRA SURGERY, IT WAS FOUND THAT THE GLOVE HAD TEARS. THERE WAS NO ADDITIONAL MEDICATION GIVEN TO THE PATIENT SINCE THEY WERE PROVIDED ANTIBIOTICS FOR THE SURGERY. THE PATIENT IS WELL.