inforMED
MalfunctionFST

NOVA 300 XENON

Received Mar 1, 2013 · Event occurred Nov 2, 2012

Report 2994044 · MDR key 2994044

Device

Generic name

Light Source, Fiberoptic

Manufacturer

Qed Medical, Inc

Model number

*

Catalog number

QED 3010

Lot number

*

Product problems

  • Off-Label Use

Patient

6 MO

  • Tissue Damage
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

NEAR THE END OF AN INCISIONAL HERNIA REPAIR ON A PATIENT, THE SURGEON NOTICED SLOUGHING OF THE SKIN AND INDURATION IN THE PERIUMBILICAL REGION. THIS INDURATION RESEMBLED A LOCALIZED 2ND DEGREE BURN. PER STAFF, THE SURGICAL HEADLAMP AND OVERHEAD LIGHT DID NOT SEEM EXCESSIVE AND OTHER SKIN AREAS EXPOSED TO SKIN PREP WERE UNAFFECTED. THIS BURN IS NOT RELATED TO USE OF AN ELECTROSURGICAL CUTTING/COAGULATION DEVICE. A WEEK LATER ANOTHER CHILD WAS UNDERGOING A SIMILAR PROCEDURE IN THE SAME ROOM AND ALSO SUSTAINED AN IDENTICAL INJURY. WE HAD OUR BIO MEDICAL DEPARTMENT INVESTIGATE A POSSIBLE CAUSE OF THE BURNS. BIO MED FOUND NOTHING WRONG WITH THE LIGHT SOURCE. THE LIGHT SOURCE WAS THEN SENT BACK TO THE MANUFACTURER AND THE MANUFACTURER RETURNED THE EQUIPMENT STATING THAT THE INCORRECT BULB HAD BEEN USED. BIO MED DID FURTHER TESTING AND WAS UNABLE TO SAY WITH CERTAINTY THAT THE INCORRECT LAMP COULD HAVE CAUSED THE BURN. HOWEVER, THE CORRECT LAMP WOULD HAVE HAD A FILTER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WAS UNGOING A SURGICAL PROCEDURE AND THE LIGHT SOURCE WAS BEING USED TO VISUALIZE THE SURGICAL FIELD.