MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-19 for MAMMOTOME MAMMOTEST SYSTEM MMT100 manufactured by Devicor Medical Products Inc..
[126104105]
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. The field service engineer confirmed the computer component of the device had a burning smell, however exhibited no signs of burning on the components. The likely cause of the failure was the capacitors on the motherboard. The cpu cooler was found to be working intermittently. 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
[126104106]
Devicor medical products inc. Received a report from affiliate, (b)(4), stating, during procedure of biopsy and first exposition of x-ray, screen of pc froze and it was not able to make any adjustments of picture. Software tools for adjustments and pictures don? T work. After that is reported that power supply of pc is down and motherboard smells of burning". This has been documented in our complaint system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008492462-2018-00083 |
| MDR Report Key | 7986079 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-21 |
| 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 | 3 |
| Brand Name | MAMMOTOME MAMMOTEST SYSTEM |
| Generic Name | BIOPSY 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 CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |