MalfunctionFCR
AUTO-IRIS FIBER LIGHT PROJECTOR
Received May 22, 1997 · Event occurred Apr 17, 1997
Report 1418479-1997-00025 · MDR key 93557
Device
Generic name
Fiber Light Projector
Manufacturer
Richard Wolf Medical Instrume.Model number
5119.00Catalog number
5119.00
Lot number
NA
Product problems
- Detachment Of Device Component
- Lead(s), burn(s) from
- Use of Device Problem
Patient
25 YR
- Burn(s)
Narrative
Description of Event or Problem
A SURGICAL PROCEDURE WAS BEING DONE USING A FIBER LIGHT RETRACTOR, LIGHT CABLE AND LIGHT SOURCE. THE CONNECTION BETWEEN THE RETRACTOR AND THE CABLE WAS NOT ENOUGH TO CAUSE A 1CM MINOR SKIN BURN WHEN THE TWO WERE INADVERTENTLY LEFT ON THE PT. THE BURN WAS TREATED WITH OINTMENT AND AN ADHESIVE BANDAGE STRIP. THE USER WAS AWARE THAT THE FIBER LIGHT SOURCE GENERATOR HAD OPERATING INSTRUCTIONS THAT INDICATE THAT LIGHT CONNECTORS CAN GET HOT ENOUGH TO CAUSE BURNS AND CARE MUST BE TAKEN DURING USE.