MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Nov 23, 2016
Report 9612030-2016-00734 · MDR key 6124890
Device
Product problems
- Break
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 UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 10-26-2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS BROKEN LITE HANDLE COVER. ADDITIONAL INFORMATION WAS REQUESTED ON 11/22/2016 AND ON 11/23/2016 WITH NO RESPONSE.