inforMED
InjuryBWN

SKYTRON

Received Oct 21, 2014 · Event occurred Jan 3, 2014

Report 1825014-2014-00014 · MDR key 4210249

Device

Generic name

Surgical Light

Manufacturer

Ddk

Model number

ST23

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING A THORACOTOMY A SURGICAL LIGHT WAS BROUGHT INTO THE FIELD AND THE LENS OPENED. REFLECTIVE MATERIAL FROM THE LENS WAS ABLE TO ENTER THE SURGICAL SITE. IT IS SUSPECTED THAT SOME PARTICLES DID LAND INSIDE THE PT. THE SURGEON ALSO NOTED WHAT SEEMED LIKE DUST IN HIS EYES FOLLOWING THE INCIDENT. BEFORE CLOSING THE CASE SKYTRON INFORMED THE SURGEON THAT THE MATERIALS MAKING UP THE REFLECTIVE MATERIAL WAS SIO AND TIO (SILICON MONOXIDE AND TITANIUM MONOXIDE RESPECTIVELY). THE SURGEON PROCEEDED WITH THE CASE AND CLOSED THE PT.