FDA Adverse Event
Other
Summary report: N
9610617-2008-00010
MDR report key: 1100909
·
Received May 16, 2008
Report
- Report Number
- 9610617-2008-00010
- Event Type
- Other
- Date Received
- May 16, 2008
- Product Code
- HRX
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE 28305BA/SCOPE IS A 1.9MM X 6.5CM 30 DEGREE SCOPE. THE SHAFT OF THE SCOPE IS BENT; THERE ARE 2+ BROKEN ROD LENSES; THERE ARE NO VISUALS. THE 28306BN SHEATH IT WAS USED WITH WAS BENT AND DENTED. THERE WAS CONSIDERABLE RESISTANCE FELT WHEN WE INTRODUCED SCOPE INTO SHEATH. WE BELIEVE THE INTERFACE BETWEEN THE SCOPE AND THE BENT SHEATH CAUSED THE SCOPE SHAFT TO BE BENT RESULTING IN BROKEN ROD LENSES AND NO VISUALS. THERE HAVE BEEN NO COMPLAINTS RECORDED ON THIS SCOPE FOR THE LAST 6 YRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HRX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |