inforMED
MalfunctionLQJ

HGM

Received Nov 17, 2000 · Event occurred Jan 1, 2000

Report 1720381-2000-00005 · MDR key 306221

Device

Generic name

Shutter

Manufacturer

Fisma

Model number

K10-A-K03-1-73

Catalog number

ZEISS THIN SHUTTER K3

Lot number

NA

Product problems

  • Failure, intermittent
  • Shutter failure

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE SHUTTER INTERMITTENTLY DID NOT CLOSE COMPLETELY THUS EXPOSING THE DOCTOR AND ASSISTANT. THE DOCTOR REPORTED THAT THIS MALFUNCTION HAD HAPPENED SEVERAL TIMES OVER THE PAST FEW MONTHS. THERE WERE NO REPORTED INJURIES.

Remedial action

  • Other