FDA Adverse Event
Other
Summary report: N
SSD015
MDR report key: 415178
·
Received September 6, 2002
Report
- Report Number
- 1824347-2002-00012
- Event Type
- Other
- Date Received
- September 6, 2002
- Report Date
- August 15, 2002
- Manufacturer
- IMAGYN MEDICAL TECHNOLOGIES, INC.
- Product Code
- KNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
GARROTE WIRE DID NOT FULLY TRANSECT. SURGEON USED SCISSORS TO FINISH TRANSECTING THE LESION. PT WAS NOT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SSD015 | SSD015 | KNW | IMAGYN MEDICAL TECHNOLOGIES, INC. | SSD015 | 15D02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |