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
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.