MalfunctionFCR
AUTO-IRIS FIBER LIGHT PROJECTOR
Received May 22, 1997 · Event occurred Mar 21, 1997
Report 1418479-1997-00024 · MDR key 93570
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
28 YR
- Burn(s)
Narrative
Description of Event or Problem
A SURGICAL PROCEDURE WAS BEING DONE USING A FIBER LIGHT RETRACTOR,M LIGHT CABLE AND LIGHT SOURCE. THE CONNECTION BETWEEN THE RETRACTOR AND THE CABLE WAS HOT ENOUGH TO CAUSE A MINOR SKIN BURN WHEN THE TWO WERE DISCONNECTED. THE BURN WAS TREATED WITH OINTMENT AND AN ADHESIVE BANDAGE STRIP. THE USER AS AWARE THAT FIBER LIGHT SOURCE GENERATOR HAS OPERATING INSTRUCTIONS THAT INDICATE THAT LIGHT CONNECTORS CAN GET HOT ENOUGH TO CAUSE BURNS AND CARE MUST BE TAKEN DURING USE.