FDA Adverse Event
Injury
Summary report: N
3.0MM SABER SUCTION WAND
MDR report key: 622040
·
Received July 6, 2005
Report
- Report Number
- 1056128-2005-00001
- Event Type
- Injury
- Date Received
- July 6, 2005
- Date of Event
- April 25, 2005
- Report Date
- May 5, 2005
- Manufacturer
- VANGUARD MEDICAL CONCEPTS, INC.
- Product Code
- JOL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
TIP DETACHED FROM ARTHROSCOPIC SUCTION WAND DURING ARTHROSCOPIC SURGERY. AN X-RAY WAS USED TO LOCATE TIP FOR REMOVAL. TIP WAS REMOVED BY SURGEON WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.0MM SABER SUCTION WAND | ORTHOPEDIC | JOL | VANGUARD MEDICAL CONCEPTS, INC. | * | 550536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |