MalfunctionLQJ
HGM
Received Feb 17, 1999 · Event occurred Jan 27, 1999
Report 1720381-1999-00002 · MDR key 210954
Device
Generic name
Argon Microfilter
Manufacturer
FismaModel number
K10-A-K03-1-73Catalog number
ZEISS THIN SHUTTER,K3 SMARTSCA
Lot number
NA
Product problems
- Defective Component
Patient
*
- Surgery, prolonged
Narrative
Description of Event or Problem
DURING MICROSURGERY PROCEDURE, SHUTTER FAILED TO CLOSE WHEN LASER FIRED. PHYSICIAN REPORTED SEEING LIGHT BEAM THROUGH SCOPE. PHYSICIAN STOPPED PROCEDURE, PUT ON SAFETY GLASSES AND COMPLETED PROCEDURE. FIELD SERVICE ENGINEER WAS CONTACTED DIRECTLY BY A PURCHASING REP FOR THE USER FACILITY BY REQUEST OF THE OPERATING ROOM SUPERVISOR. PHYSICIAN REPORTED TO FIELD SERVICE ENGINEER THAT NO INJURY TO SELF OCCURRED.
Remedial action
- Repair