FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 5994034
·
Received October 3, 2016
Report
- Report Number
- 3007591333-2016-00047
- Event Type
- Malfunction
- Date Received
- October 3, 2016
- Date of Event
- August 30, 2016
- Report Date
- September 23, 2016
- Manufacturer
- ENDOCHOICE, INC.
- Product Code
- FDF
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ON INSPECTION OF THE DEVICE AT THE SERVICE CENTER, THE ISSUE COULD NOT BE REPLICATED. A REPLACEMENT FUSEVIEW WAS SENT TO THE SITE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FUSEVIEW WOULD RESTART RANDOMLY BEFORE AND DURING CASES. THERE WAS NO PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646023 | FUSE ENDOSCOPY SYSTEM | COLONOSCOPE AND ACCESSORIES | FDF | ENDOCHOICE, INC. | FUSE SYSTEMS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |