FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 6199097
·
Received December 22, 2016
Report
- Report Number
- 3007591333-2016-00068
- Event Type
- Malfunction
- Date Received
- December 22, 2016
- Date of Event
- December 1, 2016
- Report Date
- December 21, 2016
- Manufacturer
- ENDOCHOICE, INC.
- Product Code
- FDF
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN EVALUATED BY THE MANUFACTURER. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE IMAGE WAS LOST FOLLOWING NOISE/SMOKE FROM THE DEVICE AND LACK OF POWER BUTTON FUNCTIONALITY. THERE WAS NO REPORTED PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847852 | FUSE ENDOSCOPY SYSTEM | COLONOSCOPE AND ACCESSORIES | FDF | ENDOCHOICE, INC. | FUSEBOX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |