FDA Adverse Event
Malfunction
Summary report: N
ENDOCARE CRYOCARE CRYOPROBE, 2.4MM R/ANGLE
MDR report key: 2040378
·
Received February 15, 2011
Report
- Report Number
- 3008262715-2011-00005
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 16, 2011
- Manufacturer
- HEALTHTRONICS, INC.
- Product Code
- GEH
- PMA / PMN Number
- K060279
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER INITIAL REPORT, PT WAS NOT INJURED.
Description of Event or Problem · 1
PROBE PASSED TEST BUT STARTED FROSTING UP THE SHAFT DURING FREEZE. THE DOCTOR TOOK THE NECESSARY PRECAUTIONS TO PREVENT THE SKIN FROM BEING DAMAGED. PT WAS NOT INJURED DURING THE PROCEDURE DUE TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOCARE CRYOCARE CRYOPROBE, 2.4MM R/ANGLE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | HEALTHTRONICS, INC. | PERC-24 | 09-0671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |