NS-3631 N-STER DISPOSABLE
Received Sep 6, 2016
Report 9612030-2016-00421 · MDR key 5930928
Product problems
- Crack
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED OR DATE OF MANUFACTURE IDENTIFIED AS THE LOT NUMBER WAS NOT PROVIDED. A PHOTO WAS RECEIVED AND THE REPORTED ISSUE WAS CONFIRMED; THE LITE GLOVE IS RIPPED. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. WHEN ROOT CAUSE(S) IS DETERMINED THE APPROPRIATE ACTIONS WILL BE TAKEN TO ADDRESS THE REPORTED CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
Additional Manufacturer Narrative
SUBMIT DATE: 09/06/2016. 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 REPORTED THAT THE LIGHT HANDLE COVER WAS CRACKED WHEN OPENED FOR USE.