FDA Adverse Event
Malfunction
Summary report: N
ENDOCARE CRYOCARE CRYOPROBE
MDR report key: 8203064
·
Received December 28, 2018
Report
- Report Number
- 3008262715-2018-00086
- Event Type
- Malfunction
- Date Received
- December 28, 2018
- Date of Event
- December 6, 2018
- Report Date
- February 8, 2019
- Manufacturer
- ENDOCARE INC.
- Product Code
- GEH
- PMA / PMN Number
- K153489
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY SIMULATED USE TESTING WHICH CONFIRMED THE REPORTED ISSUE OF SHAFT FROSTING. FURTHER EVALUATION FOUND A VACUUM SLEEVE FAILURE.
Description of Event or Problem · 1
3 PROBES FROM A 4 PROBE CASE FROSTED UP THE SHAFT DURING PRETESTING. COMPLAINT 2 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044154 | ENDOCARE CRYOCARE CRYOPROBE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | ENDOCARE INC. | PCS-17 | 26054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |