FDA Adverse Event
Injury
Summary report: N
POLAR WAND CRYOTHERAPY SYSEM
MDR report key: 1334506
·
Received February 26, 2009
Report
- Report Number
- 2529592-2009-00004
- Event Type
- Injury
- Date Received
- February 26, 2009
- Date of Event
- January 30, 2009
- Report Date
- February 20, 2009
- Manufacturer
- GI SUPPLY
- Product Code
- GEH
- PMA / PMN Number
- K041783
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REPRESENTATIVE PRESENT DURING PROCEDURE. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. NO DEVICE FAILURE.
Description of Event or Problem · 1
DURING CRYOTHERAPY TREATMENT FOR GASTRIC ANTRAL VASCULAR ECTASIA (GAVE), A FEMALE PATIENT DEVELOPED A PNEUMOPERITONEUM, AND WAS SCHEDULED FOR SURGERY. DURING SURGERY, A PERFORATION WAS LOCATED ON THE POSTERIOR LESSER CURVATURE OF THE STOMACH AND CLOSED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED. THERE WAS NO DEVICE MALFUNCTION DURING THE ABLATION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLAR WAND CRYOTHERAPY SYSEM | CRYOSURGICAL UNIT AND ACCESSORIES | GEH | GI SUPPLY | GIS-19 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |