MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for BREAST BIOPSY SITE MARKER BLUETOOTH II manufactured by Devicor Medical Products.
[93204114]
Patient Sequence No: 1, Text Type: N, H10
[93204115]
Circulator and lunch relief scrub tech with doctors were performing sentinel node biopsy. We successfully linked neoprobe at beginning of case and worked for first node. We were able to use to find second node and while getting ex-vivo count neoprobe stopped working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7066769 |
| MDR Report Key | 7066769 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-06-14 |
| Report Date | 2017-11-15 |
| Date Reported to FDA | 2017-11-15 |
| Date Reported to Mfgr | 2017-11-15 |
| Date Added to Maude | 2017-11-29 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | BREAST BIOPSY SITE MARKER |
| Generic Name | NEOPROBE |
| Product Code | IZD |
| Date Received | 2017-11-29 |
| Model Number | BLUETOOTH II |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS |
| Manufacturer Address | 300 E-BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |