HGM
Received Jun 12, 2002 · Event occurred May 20, 2002
Report 1720381-2002-00004 · MDR key 400077
Device
Generic name
Microscope Laser Filter
Manufacturer
FismaModel number
K10-A-K08-1-73Catalog number
ZEISS THIN SHUTTER K8
Lot number
NA
Product problems
- Intraprocedure, fire or flash during
- Device Displays Incorrect Message
Patient
*
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
DOCTOR STARTED THE PROCEDURE AND THE FIRST TIME HE FIRED THE LASER HE REPORTED SEEING A GREEN FLASH OF LIGHT. FOR THE REST OF THE PROCEDURE HE WORE SAFETY FILTER GLASSES AND COMPLETED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. LATER THE DOCTOR WAS CHECKED BY THE OPHTHALMOLOGY DEPARTMENT OF THE CLINIC AND NO INJURY WAS FOUND . BIO-TECH REPORTED THAT THERE WERE NO ERROR CODES INDICATING A FAULT CONDITION IN THE LASER SYSTEM DURING THE PROCEDURE. LATER IN THE DAY THE SHUTTER WAS CAUSED TO MALFUNCTION BY CLINIC STAFF AND AN ERROR CODE DID PREVENT THE LASER FROM FIRING. THE DEVICE THEN WAS PACKAGED AND RETURNED TO MANUFACTURER FOR EVALUATION.