MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-04 for OLYMPUS manufactured by Olympus.
[30713177]
The right paratracheal lymph node was located by ebus. Three fna samples were taken. On the 3rd pass, it was noted that the ebus needle had fractured. The ebus bronchoscope was removed and the guidewire connected to the needle was extending through the entire trachea, through the vocal cords and out of his mouth. The pt was stable. The standard bronchoscope was exchanged for the ebus and the standard bronchoscope was inserted into trachea and the wire and needle was clearly seen, with the needle stuck into the right paratracheal area. No bleeding was noted. The guidewire and needle were removed through the mouth in one piece. The ebus scope was reinserted and again the lymph node was noted with no apparent us abnormalities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057705 |
| MDR Report Key | 5207706 |
| Date Received | 2015-11-04 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-08-10 |
| Date Added to Maude | 2015-11-06 |
| 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 | RISK MANAGER |
| 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 | OLYMPUS |
| Generic Name | EBUS-TNBA ASPIRATION NEEDLE |
| Product Code | FFE |
| Date Received | 2015-11-04 |
| Lot Number | 55K, 54K OR 52K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |