MalfunctionFSW
STORZ
Received Feb 27, 2006 · Event occurred Jan 18, 2006
Report 719666 · MDR key 719666
Device
Generic name
Ent Microscope, Light
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- No Device Output
- Replace
Patient
47 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE LIGHTS WENT OUT ON THE ENT MICROSCOPE WHILE DOCTOR WAS DOING AN EAR PROCEDURE. BIOMEDICAL ENGINEERING WAS CALLED AND ANOTHER ENT MICROSCOPE WAS SUBSTITUTED. BIOMED HAS ARCHIVED THE LIGHT SOURCE BECAUSE WE CAN NOT PURCHASE THE FAILED PART FROM THE MANUFACTURER, OR A THIRD PARTY. THE LIGHT SOURCE WAS REPLACED WITH ANOTHER OLDER LIGHT SOURCE. IT SEEMS TO BE AN ACCEPTABLE TEMPORARY SOLUTION UNTIL THE ENTIRE MICROSCOPE AND LIGHT SOURCE ARE REPLACED WITH NEWER TECHNOLOGY.