FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 4963968
·
Received July 31, 2015
Report
- Report Number
- 3007591333-2015-00031
- Event Type
- Malfunction
- Date Received
- July 31, 2015
- Date of Event
- April 24, 2015
- Report Date
- July 31, 2015
- Manufacturer
- ENDOCHOICE INC.
- Product Code
- FDF
- PMA / PMN Number
- K14598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION DETERMINED THAT THE ISSUE WAS CAUSED BY A FAILURE WITH THE MONITOR.
Description of Event or Problem · 1
IT WAS REPORTED BY A USER THAT THE VIDEO DISPLAY IMAGES WERE LOST DURING A COLONOSCOPY CASE. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PT. THE MONITOR DISPLAY A WARNING MESSAGE THAT IT WAS OVERHEATING PRIOR TO THE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498868 | FUSE ENDOSCOPY SYSTEM | COLONOSCOPE AND ACCESSORIES | FDF | ENDOCHOICE INC. | NOT APPLICABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |