MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Jan 24, 2017 · Event occurred Jan 3, 2017
Report 9612030-2017-00031 · MDR key 6272919
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) 2017 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LIGHT HANDLE GLOVE RIPPED WHEN APPLIED. LIGHT HANDLE COVER MATERIAL SEEMS TO BE TOO THIN. THIS SPT IS USED DURING EMERGENCY SECTIO AND SO EXTRA CAUTION IS NEEDED