FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 5107986
·
Received September 21, 2015
Report
- Report Number
- 3007591333-2015-00048
- Event Type
- Malfunction
- Date Received
- September 21, 2015
- Date of Event
- September 8, 2015
- Report Date
- September 21, 2015
- Manufacturer
- ENDOCHOICE INC.
- Product Code
- FDF
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE ENDOCHOICE SERVICE CENTER FOR EVAL AND REPAIR. IT WAS FOUND THAT A PROBLEM WITH THE IMAGE WAS IDENTIFIED REQUIRING A REPAIR. THE CCD CAMERA ASSEMBLY WAS REPLACED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT MIDDLE SCREEN IMAGE LOSS OCCURRED DURING A CASE. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCES TO ANY PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623526 | FUSE ENDOSCOPY SYSTEM | COLONOSCOPE AND ACCESSORIES | FDF | ENDOCHOICE INC. | FUSE 1C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |