FDA Adverse Event
Other
Summary report: N
TROPHON EPR
MDR report key: 3853109
·
Received May 1, 2014
Report
- Report Number
- 3853109
- Event Type
- Other
- Date Received
- May 1, 2014
- Date of Event
- April 24, 2014
- Report Date
- May 1, 2014
- Manufacturer
- NANOSONICS INC.
- Product Code
- OUJ
- Report Source
- User Facility report
- Reporter Location
- SC, US
Narratives
Description of Event or Problem · 1
THE HEAT FROM THE TROPHON IS LOOSENING THE EPOXY THAT HOLDS THE VAGINAL PROBE TOGETHER. THE VAGINAL PROBES ARE FALLING APART. WE HAVE HAD 6 VAGINAL PROBES TO FALL APART SINCE USING THE TROPHON. THEREFORE, WE HAVE HAD TO PURCHASE NEW PROBES. THE TROPHON UTILIZES A HYDROGEN BASED CHEMICAL STERILIZATION SOLUTION. WE BELIEVE THIS MAY BE CONTRIBUTING TO THE LOOSENING OF THE EPOXY OF THE VAGINAL PROBES AND THUS CAUSING THEM TO BREAK. OUR FACILITY IS IN THE PROCESS OF RETURNING ALL 12 TROPHONS BACK TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263604 | TROPHON EPR | HIGH LEVEL DISINFECTION REPROCESSING INSTRUMENT FOR ULTRASONIC TRANSDUCERS | OUJ | NANOSONICS INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | A VAGINAL PROBE |