MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-19 for NEO2000 GAMMA DETECTION SYSTEMS * manufactured by Neoprobe Corporation.
[479694]
Patient undergoing a left modified radical mastectomy. Surgeon injected the peritumoral area with methylene blue. Using a neoprobe 2000, the surgeon attempted to localize the sentinel node unsuccessfully prior to the incision. Subsequently, an elliptical skin incision was made, which included the nipple-areolar complex extending up into the left axilla. The flap was raised superiorly, the clavicle medially to the sternum, inferior to the rectus sheath, and laterally to the latissimus dorsi. Once again, he tried to localize the sentinel node both looking for blue dye, as well as, the hand held neoprobe 2000 unsuccessfully. The neoprobe 2000 readings varied widely between high and low counts in the same area. The surgeon was required to perform an open biopsy. Therefore, he opted to perform an auxiliary node dissection. The patient was taken to the recovery room having tolerated the procedure well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 740828 |
| MDR Report Key | 740828 |
| Date Received | 2006-06-19 |
| Date of Report | 2006-06-19 |
| Date of Event | 2006-06-09 |
| Report Date | 2006-06-19 |
| Date Reported to FDA | 2006-06-19 |
| Date Added to Maude | 2006-07-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO2000 GAMMA DETECTION SYSTEMS |
| Generic Name | GAMMA DETECTION |
| Product Code | IZD |
| Date Received | 2006-06-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 728695 |
| Manufacturer | NEOPROBE CORPORATION |
| Manufacturer Address | 425 METRO PLACE N, SUITE 300 DUBLIN OH 43017 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-19 |