FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 5018731
·
Received August 12, 2015
Report
- Report Number
- 3007591333-2015-00032
- Event Type
- Malfunction
- Date Received
- August 12, 2015
- Date of Event
- July 10, 2015
- Report Date
- August 7, 2015
- Manufacturer
- ENDOCHOICE INC.
- Product Code
- FDF
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PROCESSOR UNIT WAS RETURNED FOR EVALUATION, BUT THE CAUSE OF THE EVENT REPORTED COULD NOT BE DETERMINED. THE DEVICE OPERATED NORMALLY WHEN TESTED AT THE SERVICE CENTER.
Description of Event or Problem · 1
IT WAS REPORTED BY A USER THAT THE VIDEO DISPLAY IMAGES WERE LOST DURING A COLONOSCOPY CASE, REQUIRING REBOOT OF THE VIDEO PROCESSOR TO CONTINUE. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529270 | FUSE ENDOSCOPY SYSTEM | FDF | ENDOCHOICE INC. | FUSEBOX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |