CRYO PROBE: EXTENDED RETINAL, 2.5 MM
Received Sep 20, 2019
Report 1222074-2019-00028 · MDR key 9097217
Device
Generic name
Disposable Cryoprobes
Catalog number
1540.D
Lot number
2000403371
Product problems
- Gas/Air Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WITH REGARDS TO THIS COMPLAINT, ONE 2.5 MM EXTENDED RETINAL CRYO PROBE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE CONNECTOR OF THE PROBE REVEALED NO ANOMALIES. AFTER VISUAL INSPECTION, THE CRYO PROBE WAS SUBMERGED IN WATER AND TESTED FOR LEAKAGE AT 1030 PSI. NO SIGNS OF LEAKAGE WERE OBSERVED. AFTER THE LEAK TEST, THE PROBE WAS CONNECTED TO A CRYOSTAR AND TESTED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AGAIN, NO SIGNS OF LEAKAGE WERE DETECTED AND THE PROBE APPEARED TO BE FUNCTIONING PROPERLY. BASED ON THE INVESTIGATION PERFORMED, THE ALLEGED LEAKAGE FROM THE CONNECTOR COULD NOT BE ATTRIBUTED TO THE RETURNED CRYO PROBE.
Description of Event or Problem
GAS LEAKAGE NOTED AT THE CONNECTOR POINT WHERE IT ATTACHES ONTO CRYOMACHINE. WHEN PEDAL IS DEPRESSED, NO LEAKAGE CAN BE HEARD. ONCE PEDAL IS RELEASED BEFORE MACHINE EXPELS EXCESS GAS, HISSING FROM CONNECTOR CAN BE HEARD. CRYO WORKED FINE ON PATIENT AND COMPLETED WITHOUT ANY PROBLEMS. STAFF CONCERNED ON LEAKING CONNECTOR. VIDEO ATTACHED.
Additional Manufacturer Narrative
AN INVESTIGATION OF THE COMPLAINT ARTICLE HAS BEEN INITIATED BY D.O.R.C. R&D DEPARTMENT.
Description of Event or Problem
GAS LEAKAGE NOTED AT THE CONNECTOR POINT WHERE IT ATTACHES ONTO CRYOMACHINE. WHEN PEDAL IS DEPRESSED, NO LEAKAGE CAN BE HEARD. ONCE PEDAL IS RELEASED BEFORE MACHINE EXPELS EXCESS GAS, HISSING FROM CONNECTOR CAN BE HEARD. CRYO WORKED FINE ON PATIENT AND COMPLETED WITHOUT ANY PROBLEMS. STAFF CONCERNED ON LEAKING CONNECTOR.