CRYOMATIC
Received Oct 2, 2015 · Event occurred Sep 15, 2015
Report 5123513 · MDR key 5123513
Device
Generic name
Unit, Cryophthalmic, Ac-powered
Manufacturer
Keeler Instruments, Inc.Product problems
- Difficult to Remove
- Device Operates Differently Than Expected
Patient
67 YR
- Laceration(s)
Narrative
Description of Event or Problem
PATIENT WAS UNDERGOING RIGHT EYE PNEUMATIC RETINOPEXY TO REPAIR RIGHT RETINAL DETACHMENT. REPORTEDLY, THE CRYOPROBE HAD BEEN CHECKED BY STAFF PRIOR TO PROCEDURE AND FOUND TO FROST/DEFROST APPROPRIATELY. PER MEDICAL RECORD, APPROXIMATELY THREE TO FOUR CRYOTHERAPY SPOTS WERE PLACED AROUND THE RETINAL TEAR WITHOUT INCIDENT. HOWEVER, ON THE FOURTH ACTIVATION THE PROBE WOULD NOT DEFROST FOLLOWING DEACTIVATION OF THE FOOT PEDAL AND COULD NOT BE REMOVED. REPORTEDLY, THIS RESULTED IN A PROLONGED FREEZE. SURGEON THEN PLACED COUNTERTRACTION ON THE GLOBE IN ORDER TO REMOVE THE PROBE. PATIENT SUSTAINED A CONJUNCTIVAL LACERATION WHICH WAS REPAIRED WITH TWO SUTURES. THE CRYOMACHINE WAS TAKEN OUT OF SERVICE AND REPLACED WITH A SECOND MACHINE. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT.