MalfunctionDYN
450 SAL EJECTOR 3283
Received Aug 30, 2007 · Event occurred Jul 9, 2007
Report 9612030-2007-00041 · MDR key 904255
Device
Generic name
Dental Ejector
Manufacturer
Tyco/kendall HealthcareModel number
8881450004Catalog number
8881450004
Lot number
630303864
Product problems
- Detachment Of Device Component
Patient
NA YR
- No Patient involvement
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 TYCO/KENDALL HEALTHCARE THAT A CUSTOMER HAD A PROBLEM WITH THE DENTAL SAL EJECTOR. THE DEALER REPORTS THAT THE TIP OF THE SALIVA EJECTOR FELL OFF WHEN IT WAS BEING MANIPULATED BY THE OFFICE STAFF. THE EJECTOR WAS GRABBED BY THE BLUE TIP, AND BY THE SHAFT, AND THE BLUE TIP BROKE OFF. THE EJECTOR WAS NOT IN USE ON A PATIENT WHEN THE TIP FELL OFF."