FDA Adverse Event
Malfunction
Summary report: N
2250051-2009-00068
MDR report key: 1340843
·
Received February 19, 2009
Report
- Report Number
- 2250051-2009-00068
- Event Type
- Malfunction
- Date Received
- February 19, 2009
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SVC ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED BENT TIP CLAMPS IN POSITIONS 1 AND 2. FSE TESTED LLD WITH SPLLD TEST AND TESTED SUMMIT WITH OAS USER SOFTWARE TEST. 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 |