MalfunctionELC
AMERICAN EAGLE P 204SD 3/8"
Received Dec 2, 2016 · Event occurred Nov 21, 2016
Report MW5066533 · MDR key 6147340
Device
Generic name
Resin Handle Scaler
Manufacturer
American Eagle Instruments Inc.Model number
204SDCatalog number
AES204SDXPX
Lot number
6BD
Product problems
- Break
Patient
Not reported
- Vessel Or Plaque, Device Embedded In
- Vessel Or Plaque, Device Embedded In
Narrative
Description of Event or Problem
WHILE SCALING THE DISTAL-LINGUAL OF PATIENT'S TOOTH #1 THE TIP OF AN AMERICAN EAGLE XP 204S SCALER BROKE 2MM BELOW THE GUM LINE AND WE WERE UNABLE TO LOCATE THE TIP. WE SENT THE PATIENT TO A PERIODONTIST AND THE TIP WAS REMOVED QUICKLY AND EASILY. THIS SCALER WAS USED AFTER THE USAGE OF A PIEZO AND CURETTE. FINE SCALING WAS THE INTENDED TECHNIQUE WITH THIS INSTRUMENT. INSTRUMENT TIP LODGED SUBGINGIVALLY DISTAL TO #1 AND HAD TO REFER TO PATIENT TO PERIODONTIST TO HAVE TIP REMOVED.