MalfunctionLQJ
HGM
Received Jul 29, 1998 · Event occurred Jun 26, 1998
Report 1720381-1998-00007 · MDR key 180826
Device
Generic name
Laser Slit Lamp Attachment
Manufacturer
Fisma, Inc.Model number
A01-A-K03-0-02Catalog number
PLANAR F
Lot number
NA
Product problems
- Dislodged
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PHYSICIAN REC'D EXPOSURE WHEN THE RIGHT FILTER TO HIS PLANAR F FELL OUT OF ITS HOLDER. PHYSICIAN STATED THAT HE DID NOT NOTICE THE FILTER WAS MISSING UNTIL AFTER COMPLETING THE PROCEDURE (LASER TREBECULAPLASTIE AT THE POWER SETTING OF 600 MILLIWATTS). HE ALSO STATED THAT HE DID NOT RECEIVE ANY INJURY.
Remedial action
- Repair