FDA Adverse Event
Other
Summary report: N
9610617-2007-00029
MDR report key: 981403
·
Received November 21, 2007
Report
- Report Number
- 9610617-2007-00029
- Event Type
- Other
- Date Received
- November 21, 2007
- Product Code
- FFK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
CHECKED ALL FUNCTIONS THE ONLY PROBLEM FOUND WITH THE INSTRUMENT 27076A WAS THE LEVER ON THE LOCKING COLLAR FOR THE TELESCOPE IS STRIPPED AND NEEDS REPLACING. THE LOCKING LEVER HAS NO EFFECT ON THE ASSEMBLY OR ALIGNMENT OF THE JAWS ON THIS INSTRUMENT; THE ONLY FUNCTION IT HAS IS TO LOCK THE SCOPE IN THE CHANNEL ONCE THE INSTRUMENT IS ASSEMBLED. THERE WAS NO PROBLEM FOUND WITH THE FUNCTIONING OF THE INSTRUMENT. HOSPITAL ALSO REPORTED THAT THEY BELIEVE THERE WAS NO MALFUNCTION OF THE INSTRUMENT, BUT RATHER A POSSIBLE USER ERROR IN NOT TIGHTENING FRONT SCREW PEG WHICH WOULD HAVE KEPT JAWS ALIGNED CORRECTLY AND MADE REMOVAL POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FFK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |