FDA Adverse Event
Malfunction
Summary report: N
ENDOCARE CRYOCARE CRYOPROBE, R1.7MM R/ANGLE
MDR report key: 2054116
·
Received March 2, 2011
Report
- Report Number
- 3008262715-2011-00004
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED PROBE WAS VISUALLY AND FUNCTIONALLY EVALUATED AND THE ISSUE WAS CONFIRMED. THE SHAFT FROSTED DUE TO A VACUUM FAILURE. DEVICE HISTORY REVIEW SHOWED THERE WAS ONE RELATED ISSUE WITH FINAL ASSEMBLY LOT #09-0594. THE VACUUM TUBE LOT, USED IN THE FINAL ASSEMBLY, HAD BEEN 100% TESTED WITH NO FAILURES REPORTED.
Description of Event or Problem · 1
DURING PRETEST CYCLE, ICE FORMED ON THE ENTIRE SHAFT OF THE CRYOPROBE. TEST WAS TERMINATED AND THE PROBE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOCARE CRYOCARE CRYOPROBE, R1.7MM R/ANGLE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | HEALTHTRONICS, INC. | R1.7 | 09-0633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |