FDA Adverse Event
Injury
Summary report: N
VISUAL-ICE CRYOABLATION SYSTEM
MDR report key: 3104760
·
Received May 7, 2013
Report
- Report Number
- 3004462490-2013-00009
- Event Type
- Injury
- Date Received
- May 7, 2013
- Date of Event
- February 22, 2013
- Report Date
- April 12, 2013
- Manufacturer
- GALIL MEDICAL INC.
- Product Code
- GEH
- PMA / PMN Number
- K113860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO MALFUNCTION OR ISSUES WITH THE DEVICE WERE REPORTED. THIS ADVERSE EVENT WAS COLLECTED AS PART OF A CLINICAL STUDY. PNEUMOTHORAX IS A KNOWN POTENTIAL ADVERSE EVENT FROM CRYOABLATION PROCEDURES AND IS DOCUMENTED AS SUCH IN THE PRODUCT IFU AND USER MANUAL. THE PT WAS TREATED AND THE ISSUE WAS RESOLVED.
Description of Event or Problem · 1
IT WAS REPORTED A (B)(4) STUDY OF A PT WAS DIAGNOSED WITH PNEUMOTHORAX ON (B)(6) 2013. CTCAE GRADE 2, REQUIRING THORACENTESIS ON (B)(6) 2013. EVENT NOTED TO BE RELATED TO THE CRYOABLATION PROCEDURE AND IS A KNOWN POTENTIAL AE RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199556 | VISUAL-ICE CRYOABLATION SYSTEM | CRYOSURGICAL UNIT, ACCESSORIES | GEH | GALIL MEDICAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |