FDA Adverse Event
Malfunction
Summary report: N
CRYOMAZE
MDR report key: 1647089
·
Received March 23, 2010
Report
- Report Number
- 1647089
- Event Type
- Malfunction
- Date Received
- March 23, 2010
- Date of Event
- March 11, 2010
- Report Date
- March 23, 2010
- Manufacturer
- ATS MEDICAL INC.
- Product Code
- OCL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
THE PHYSICIAN WAS ATTEMPTING TO PERFORM A CRYOABLATION BUT THE MACHINE WAS NOT PICKING UP THE PROBE. THE SALES REP WAS CALLED TO ADDRESS THE PROBLEM, BUT THE MACHINE WOULD STILL NOT RECOGNIZE THE PROBE. A SECOND PROBE WAS OPENED AND WORKED AS EXPECTED, WITH NO PROBLEMS NOTED. THERE WAS NO APPARENT INJURY TO THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN====================== MANUFACTURER RESPONSE FOR CRYOMAZE CLAMP AND SURGICAL ABLATION PROBE, ATS======================MANUFACTURER PROVIDED RGA# FOR PRODUCT RETURN EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOMAZE | PROBE, ABLATION, CRYO, CARDIAC | OCL | ATS MEDICAL INC. | 60CM1 | 50046590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |