MalfunctionHKY
KEELER CRYOMASTER
Received Jan 29, 2014 · Event occurred Dec 3, 2013
Report 1000391004-2014-00001 · MDR key 3727381
Device
Generic name
Cryosurgical Console
Manufacturer
Keeler Ltd.Model number
CRYOMASTERCatalog number
2502K8035/2502K8040
Product problems
- Loose or Intermittent Connection
- Device Operates Differently Than Expected
- Naturally Worn
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING A CRYOSURGICAL PROCEDURE THE DEVICE ENTERED INTO A PURGING STATE UNEXPECTEDLY. DURING THE TIME THE TIP REMAINED FROZEN AND IN CONTACT WITH THE PATIENT'S EYE, AND IT WAS NOT POSSIBLE TO BREAK CONTACT WITH THE EYE UNTIL THE TIP HAD DEFROSTED FOR FEAR OF CAUSING HARM TO THE PT. IT WAS NECESSARY FOR THE PROCEDURE TO BE HALTED. THE PT WAS SEEN IN CLINIC SHORTLY AFTER THE EVENT, AND IT WAS DETERMINED THAT NO DAMAGE HAD OCCURRED AS A RESULT. THIS EVENT OCCURRED IN THE (B)(6), AND HAS BEEN REGISTERED WITH THE (B)(6).
Remedial action
- Inspection