MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-01 for TROPHON EPR * E8350NA manufactured by Nanosonics Inc..
[20700868]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3853109 |
| MDR Report Key | 3853109 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-24 |
| Report Date | 2014-05-01 |
| Date Reported to FDA | 2014-05-01 |
| Date Reported to Mfgr | 2014-06-06 |
| Date Added to Maude | 2014-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROPHON EPR |
| Generic Name | HIGH LEVEL DISINFECTION REPROCESSING INSTRUMENT FOR ULTRASONIC TRANSDUCERS |
| Product Code | OUJ |
| Date Received | 2014-05-01 |
| Model Number | * |
| Catalog Number | E8350NA |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NANOSONICS INC. |
| Manufacturer Address | 1209 KINGSLEY CT LOWER GWYNEDD PA 19002 US 19002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-01 |