HELIUM CYLINDER UHP6K
Received Dec 5, 2017 · Event occurred Oct 24, 2017
Report MW5073754 · MDR key 7086701
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A TUMOR CRYOABLATION DEVICE FROM HEALTHTRONICS WAS TESTED IN THE (B)(6) HOSPITAL OPERATING ROOM JUST PRIOR TO USE. PATIENT WAS ANESTHETIZED AND PREPARED FOR PROCEDURE. THE DEVICE USES ARGON GAS TO FREEZE THE STERILE PROBE, HELIUM TO WARM IT BACK UP. AFTER FREEZING, IT WAS FOUND THAT THE PROCEDURE TO WARM THE PROBE DID NOT WORK. THE PROCEDURE WAS CANCELED WITH NO ADVERSE EFFECT ON PATIENT. THE MFG. REP RETURNED THE NEXT DAY TO TROUBLESHOOT THE PROBLEM. IT WAS CONFIRMED THAT 3 HELIUM TANKS IN THE SAME LOT DID NOT WARM THE PROBE BUT INSTEAD, COOLED IT TO AROUND MINUS 7 DEGREES C. TESTING WITH A HELIUM TANK FROM ANOTHER LOT NUMBER CONFIRMED THAT THE DEVICE OPERATED PROPERLY.