MalfunctionLQJ
HGM
Received Oct 16, 2001 · Event occurred Sep 19, 2001
Report 1720381-2001-00007 · MDR key 357031
Device
Generic name
Shutter
Manufacturer
FismaModel number
K10-A-K03-1-87Catalog number
WILD THIN SHUTTER
Lot number
NA
Product problems
- Intraprocedure, fire or flash during
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THE DOCTOR RECEIVED A FLASHBACK OF LASER LIGHT AFTER GOING THROUGH THE STANDARD SAFETY PROTOCOL. THE EVENT HAPPENED TWICE. THERE WAS NO HARM TO THE PATIENT. THE DOCTOR WAS NOT INJURED AND FINISHED THE PROCEDURE WITHOUT USING THE LASER.
Remedial action
- Repair