FDA Adverse Event
Malfunction
Summary report: N
GLIDESCOPE GVL 3
MDR report key: 2972144
·
Received February 15, 2013
Report
- Report Number
- 9615393-2013-00075
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- VERATHON MEDICAL (CANADA) ULC.
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED ISSUE WAS CONFIRMED BY VISUAL INSPECTION. THE CASING WAS CRACKED ON THE HANDLE. THE DEVICE WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A CRACK IN THE BLADE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69492 | GLIDESCOPE GVL 3 | NONE | CCW | VERATHON MEDICAL (CANADA) ULC. | 0574-0007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |