MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for 22G CELIAC PLEXUS NEEDLE GF-UC140P-AL5 manufactured by Olympus Corporation Of The Americas.
[176685189]
During an outpatient eus with celiac plexus neurolysis procedure, the 22 g celiac plexus needle was advanced into the eus scope. When the scope exited the patient? S mouth, the needle appeared to be extruded from the sheath of the scope. Am egd was performed immediately to asses for suspicious damage from the needle. Superficial tissue bleeding was noted in the stomach and esophagus. A chest xray will be completed post procedure. The patient was intubated under general anesthesia during this incident. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092502 |
| MDR Report Key | 9632142 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-01-27 |
| 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 | 3 |
| Brand Name | 22G CELIAC PLEXUS NEEDLE |
| Generic Name | NEUROLYSIS NEEDLE |
| Product Code | BSP |
| Date Received | 2020-01-24 |
| Model Number | GF-UC140P-AL5 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |