FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 83 PLUS
MDR report key: 5336428
·
Received December 30, 2015
Report
- Report Number
- 3007082252-2015-00016
- Event Type
- Malfunction
- Date Received
- December 30, 2015
- Date of Event
- December 1, 2015
- Report Date
- December 30, 2015
- Manufacturer
- CUSTOM ULTRASONICS INC.
- Product Code
- FEB
- PMA / PMN Number
- K983017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS DENIED THAT THE SYSTEM 83 PLUS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AS ALLEGED IN LAWSUIT.
Additional Manufacturer Narrative · 1
THIS MATTER AND ANY INVESTIGATION RELATED TO THE SAME IS OFFICIALLY CLOSED. THE COMPLAINT ONLY AROSE SOLELY OUT OF ALLEGATIONS IN LAWSUIT AND THIS LAWSUIT HAS BEEN RESOLVED WITH ABSOLUTELY NO FINDING OF LIABILITY OR WRONG DOING ON BEHALF OF CUSTOM ULTRASONICS, INC.
Description of Event or Problem · 1
ADVERSE EVENT AS ALLEGED SOLELY IN A LAWSUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858301 | SYSTEM 83 PLUS | ENDOSCOPE WASHER-DISINFECTOR | FEB | CUSTOM ULTRASONICS INC. | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |