FDA Adverse Event
Malfunction
Summary report: N
ENDOCARE CRYOCARE CRYOPROBE
MDR report key: 1925816
·
Received November 8, 2010
Report
- Report Number
- 3008262715-2010-00085
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 6, 2010
- Manufacturer
- HEALTHTRONICS, INC.
- Product Code
- GEH
- PMA / PMN Number
- K060279
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONFIRMED SHAFT FROSTING DUE TO VACUUM FAILURE. PHYSICIAN REPORTED NO COMPLICATIONS FROM PROBE FAILURE.
Description of Event or Problem · 1
PROBE #1 FROZE IN THE PATIENT. UNABLE TO GET TEMPERATURE OF THE PROBE AS LOW AS THE OTHERS. WE THEN DISCOVERED THE SHAFT WAS FROZEN ALL THE WAY TO THE HUB. SHUT DOWN PROBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOCARE CRYOCARE CRYOPROBE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | HEALTHTRONICS, INC. | CRYO-44F | 10-0008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |