MalfunctionHBI
STORZ LIGHT PIPE 20 GAUGE
Received Jan 17, 1997 · Event occurred Dec 18, 1996
Report 1920664-1997-00046 · MDR key 64617
Device
Generic name
Light Pipe
Manufacturer
Storz Instrument Co.Model number
NACatalog number
MVS1011A
Lot number
NA
Product problems
- Device Issue
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DESIGN REVISIONS ARE BEING CONSIDERED TO REDUCE THE SHADOWS BEING PRODUCED BY THIS DEVICE.
Description of Event or Problem
DURING A VITREO RETINAL PROCEDURE, THE PHYSICIAN REPORTED THAT THE LENGTH OF THE PROCEDURE WAS INCREASED APPROX. TWO HRS BECAUSE THERE WAS INSUFFICIENT LIGHT COMING FROM THIS LITE PIPE. THREE DIFFERENT LITE PIPES, FROM DIFFERENT LOTS, WERE TRIED AND ALL HAD DIFFERENT DEGREES OF DARK SPOTS. THERE WAS NO ADVERSE EFFECT ON THE PT.