MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for NODE SEEKER INTRAMEDICAL IMAGING S# IMI-NS-1 manufactured by Intramedical Imaging Llc.
[32750189]
During a right total mastectomy and sentinel node biopsy, the wireless node seeker probe malfunctioned. The wireless node seeker probe would not sync with the node seeker control unit. As a result, the operation was prolonged while obtaining a functioning node seeker probe from another location. The node seeker probe was sent to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058289 |
| MDR Report Key | 5267523 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-10-23 |
| Date Added to Maude | 2015-12-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NODE SEEKER |
| Generic Name | SEED DETECTOR |
| Product Code | IZD |
| Date Received | 2015-12-01 |
| Model Number | INTRAMEDICAL IMAGING S# IMI-NS-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTRAMEDICAL IMAGING LLC |
| Manufacturer Address | HAWTHORNE CA 90250 US 90250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-01 |