MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for OLYMPUS NA-201SX-4022 RL429600M manufactured by Olympus Medical Systems Corp..
[182992078]
The needle comes with the wire in place, the needle is passed down ebus (endo bronchial ultra sound) bronchoscope, the wire is removed. Several passes in questionable tissue are made in order to achieve a sample for specimen. The needle is removed from the patient and ebus scope and the wire is re-inserted into the needle to expel the sample. In this instance, the wire would not re-insert without out great force. Usually this part of the procedure should take less than 30 seconds to re-advance the wire, and it took several minutes with multiple staff trying to advance. This also happened on the previous case - the staff went through 3 needles on the first procedure. All needles were from the same box with the same lot #.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817906 |
| MDR Report Key | 9817906 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-20 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| 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 | 3 |
| Brand Name | OLYMPUS |
| Generic Name | BIOPSY NEEDLE |
| Product Code | FCG |
| Date Received | 2020-03-11 |
| Model Number | NA-201SX-4022 |
| Catalog Number | RL429600M |
| Lot Number | V9612 / 96V |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |