FDA Adverse Event
Malfunction
Summary report: N
BOM 7MM EXTENDED LENGTH ENDOSCOPE
MDR report key: 5417613
·
Received February 8, 2016
Report
- Report Number
- 2242352-2016-00124
- Event Type
- Malfunction
- Date Received
- February 8, 2016
- Report Date
- January 12, 2016
- Manufacturer
- MAQUET CV
- Product Code
- GCJ
- PMA / PMN Number
- K014250
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76408 | BOM 7MM EXTENDED LENGTH ENDOSCOPE | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | MAQUET CV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |