inforMED
MalfunctionEAY

ELIPAR HIGHLIGHT

Received Jul 8, 1998 · Event occurred Mar 4, 1998

Report 9611385-1998-00004 · MDR key 176158

Device

Generic name

Light Curing Unit

Model number

NA

Catalog number

076700

Lot number

NA

Product problems

  • Overheating of Device

Patient

UNKNOWN

  • Blister(s)
  • Burn(s)

Narrative

Description of Event or Problem

ON JUNE 10TH, A DENTIST CALLED AND REPORTED OF BURNING-BLISTERING AT THE GINGIVA AROUND A TOOTH AFTER APPLICATION OF ELIPAR HIGHLIGHT FOR LIGHT CURING OF A COMPOSITE RESTORATIVE MATERIAL, WHICH THE DENTIST BELIEVED MAY HAVE BEEN DUE TO THE DEVELOPMENT OF HEAT DURING THE APPLICATION OF THE LIGHT SOURCE. THE PT WAS TREATED BY COOLING THE GINGIVE, FOLLOWED BY IRRIGATING WITH CHLORHEXAMED. AFTER ONE WEEK THE PT'S GINGIVE HAS BEEN COMPLETELY RECOVERED. ALTHOUGH THE EVENT OCCURRED ON MARCH 4, 1998, ESPE WAS NOT NOTIFIED UNTIL JUNE 10. DUE TO THE PT'S DEEP CAVITY, THE DENTIST PERFORMED A SUBGINGIVAL DISSECTION USING RETRACTION FIBERS. TWO PINS WERE INSERTED INTO THE ROOT CANAL AND COATED WITH - PROBABLY 2 LAYERS OF - VIVADENT'S TETRIC COMPOSITE RESTORATIVE MATERIAL. LIGHT CURING WAS UNDERTAKEN TWO TIMES (40 SECONDS EACH TIME). THE "ONE-STEP MODUS" WAS USED AT THE HIGHEST LIGHT INTENSITY. THE TOOTH SUBSEQUENTLY WAS CROWNED.

Remedial action

  • Other