inforMED
MalfunctionFCW

FOC158/75 FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM

Received Feb 7, 2024 · Event occurred Dec 6, 2023

Report 18658341 · MDR key 18658341

Device

Generic name

Light Source, Fiberoptic, Routine

Model number

FOC158/75

Catalog number

FOC158/75

Patient

74 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE LIGHT CARRIER CORD FOR THE FACELIFT RETRACTOR, WITHOUT THE HANDHELD PIECE ATTACHED, FELL FROM THE MAYO STAND, WHILE THE LIGHT WAS STILL ON 100%. THE CORD FELL ONTO THE DRAPES OVER THE PATIENT'S ABDOMEN RESULTING IN A 1 MM BURN HOLE IN THE DRAPE. THE PATIENT'S SKIN WAS NOT BURNED AND THERE WAS NO INJURY AS A RESULT. THE FACELIFT RETRACTOR AND CORD DO NOT GIVE ANY WARNINGS WHEN OVERHEATED OR WHEN THE DEVICE HAS NOT BEEN IN USE FOR A SPECIFIED PERIOD OF TIME.