XPZC 13-14 CURETTE
Received Jan 20, 2015 · Event occurred Nov 30, 2014
Report 1000127001-2014-00001 · MDR key 4456932
Device
Generic name
Universal Curette
Manufacturer
American Eagle Instruments, Inc.Model number
XPZC13-14Catalog number
XPZC13-14
Lot number
0IB
Product problems
- Loose or Intermittent Connection
- Detachment of Device or Device Component
Patient
30 YR
- Injury
Narrative
Description of Event or Problem
I WAS NOT ABLE TO INTERVIEW THE CUSTOMER/END-USER WHO WAS WORKING WITH THE PRODUCT WHEN THEY EXPERIENCED THE EVENT. I HAD VERY LIMITED INFO AVAILABLE TO ME. A 4+ YEAR OLD DENTAL HAND INSTRUMENT (SPECIFICALLY A CURETTE WITH A LIFE EXPECTANCY OF 6-12 MONTHS) WAS BEING USED ON A PATIENT'S MOUTH (UNSURE OF THE EXACT PROCEDURE BEING PERFORMED) WHEN THE POINT OF THE INSTRUMENT (THE WORKING PORTION) CAME OUT OF THE INSERT (A COMPONENT OF THE HANDLE PORTION OF THE INSTRUMENT WHICH JOINS THE POINT TO THE HANDLE) AND LODGED IN THE PATIENTS THROAT. THE LOOSE POINT WAS REMOVED RESULTING IN 'MINOR' INJURY TO THE PATIENT. THERE WAS NO INDICATION OF WHAT ACTION OR ACTIVITY TOOK PLACE OR WAS TAKING PLACE TO CAUSE THE POINT TO COME OUT OF THE INSERT.