3611 LITE GLOVE
Received Aug 22, 2016 · Event occurred Aug 10, 2016
Report 9612030-2016-00380 · MDR key 5893565
Device
Product problems
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER WAS PROVIDED; HOWEVER, THE LOT PROVIDED WAS INCORRECT. A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. A DECONTAMINATED SAMPLE WITHOUT ORIGINAL PACKAGE OR LOT NUMBER 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: 08/22/2016. 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 REPORTS THAT WHILE PLACING THE SCIALYTIC LAMP, THE PHYSICIAN NOTICED THAT THE HANDLE OF THE DEVICE WAS SPLIT. THERE WAS NO HARM TO THE PATIENT, NO EXTRA SURGERY TIME.