FDA Adverse Event
Malfunction
Summary report: N
HORIZON APPLIER SMALL 8" CVD
MDR report key: 3050299
·
Received April 8, 2013
Report
- Report Number
- 1044475-2013-00049
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 18, 2013
- Manufacturer
- TELEFLEX
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE CLIP STAYED IN THE APPLIER AFTER THE SURGEON ATTACHED CLIP TO VESSEL. WHEN THE SURGEON ATTEMPTED TO REMOVE APPLIER IT STUCK TO THE VESSEL, CAUSING INJURY TO VESSEL. CURRENT PT'S CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142511 | HORIZON APPLIER SMALL 8" CVD | LIGATING APPLIER | GDO | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |