MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for MAMMOTEST, BIOPSY TABLE MMT100 manufactured by Devicor Medical Products, Inc..
[126110370]
The mammotome mammotest system is used for minimally invasive breast biopsy procedures. The system uses x-ray guidance for stereotactic localization, allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. Devicor field service engineer evaluated the device and found the cause of the burning smell to be related to capacity on 24v power card. Excessive current draw from a short circuit; 24v to ground. It is not likely that this short circuit would have led to a fire in the device. Although there was no patient consequence, due to the remote potential of this malfunction to cause or contribute to death or serious injury as a result of a remote potential of device fire, this has been determined to be reportable pursuant to 21 cfr 803.
Patient Sequence No: 1, Text Type: N, H10
[126110371]
Devicor medical products received a report from affiliate stating, the generator is heated up and smells like something is burning. This has been documented in our complaint system as record (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008492462-2018-00066 |
| MDR Report Key | 7984814 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JILL BURNETT |
| Manufacturer Street | 300 E. BUSINESS WAY |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer Phone | 5138649047 |
| Manufacturer G1 | DEVICOR MEDICAL PRODUCTS INC. |
| Manufacturer Street | 300 E. BUSINESS WAY |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45241 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAMMOTEST, BIOPSY TABLE |
| Generic Name | MAMMOGRAPHY TABLE |
| Product Code | IZH |
| Date Received | 2018-10-19 |
| Model Number | MMT100 |
| Catalog Number | MMT100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 300 E. BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |