FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 1812664
·
Received August 18, 2010
Report
- Report Number
- 1812664
- Event Type
- Malfunction
- Date Received
- August 18, 2010
- Date of Event
- July 22, 2010
- Report Date
- August 16, 2010
- Manufacturer
- UNK
- Product Code
- HNQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A CATARACT EXTRACTION, THE SURGEON NOTED THAT THE TIP OF THE NAGAHARA CHOPPER WAS MISSING. THE EYE WAS INSPECTED UNDER THE MICROSCOPE AND AN XRAY WAS TAKEN, THE OBJECT WAS NOT FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | NAGAHARA CHOPPER | HNQ | UNK | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |