FDA Adverse Event
Malfunction
Summary report: N
2250051-2009-00033
MDR report key: 1317639
·
Received February 4, 2009
Report
- Report Number
- 2250051-2009-00033
- Event Type
- Malfunction
- Date Received
- February 4, 2009
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND VERIFIED THE HOLD AND PULL FORCES WERE IN SPECIFICATION. FSE ALSO CALIBRATED TIP TAKE UP. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |