FDA Adverse Event
Malfunction
Summary report: N
USA ELITE M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE
MDR report key: 299020
·
Received September 28, 2000
Report
- Report Number
- 1218764-2000-00010
- Event Type
- Malfunction
- Date Received
- September 28, 2000
- Report Date
- September 26, 2000
- Manufacturer
- CIRCON ACMI
- Product Code
- FBP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, SPACERS AND ROD LENSES FELL OUT OF SHAFT OF TELESCOPE. IT IS NOT KNOWN IF THIS HAPPENED DURING A PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | USA ELITE M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE | TELESCOPE | FBP | CIRCON ACMI | M3-30A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |