FDA Adverse Event
Malfunction
Summary report: N
SONASTAR XS-E MODEL
MDR report key: 1082157
·
Received July 25, 2008
Report
- Report Number
- 2916714-2008-00016
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 9, 2008
- Report Date
- July 9, 2008
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TWO UNITS WERE INVOLVED IN THE SAME INCIDENT. FACILITY COULD NOT GET EITHER UNIT TO WORK.
Description of Event or Problem · 1
UNITS ARE DISPLAYING E1, E2, E4 ERRORS. FACILITY WAS SETTING UP FOR A CRANIOTOMY. ATTEMPTED SET UP WITH BOTH FACILITY OWNED UNITS AND ACCESSORY SETS. COULD NOT GET UNITS TO WORK. TOTAL TIME DELAY WAS 20 - 30 MINUTES GOING FROM MACHINE TO MACHINE WITH HANDPIECES. WERE ABLE TO REMOVE THE TUMOR; HOWEVER, WERE NEVER ABLE TO USE ASPIRATOR. SURGERY WAS COMPLETED AS EXPECTED. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONASTAR XS-E MODEL | LFL | MISONIX, INC. | NC553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |