MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Jan 24, 2017 · Event occurred Nov 14, 2016
Report 9612030-2017-00032 · MDR key 6274368
Device
Product problems
- Material Integrity Problem
- 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 A CUSTOMER HAD AN ISSUE WITH LITE GLOVES. THE CUSTOMER REPORTS THE LITE GLOVES ARE BREAKING EASILY WHEN INSTALLED ON THE LIGHT HANDLES PRIOR TO SURGERY. THE PLASTIC MATERIAL APPEARS TO BE TOO WEAK AND TEARS OPEN. NO PATIENT IMPACT.