MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for SINGLE USE ASPIRATION NEEDLE NA-201SX-4021 manufactured by Olympus Medical Systems Corp..
[182956350]
Endobronchial ultrasound (ebus) needle broke on attempted entry into target. No damage noted to scope or patient at this time. A 2nd needle had to be used to finish the case. 2nd case of needle malfunction noted. Location: lung nodule.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817620 |
| MDR Report Key | 9817620 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-25 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| 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 | 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 | SINGLE USE ASPIRATION NEEDLE |
| Generic Name | BIOPSY NEEDLE |
| Product Code | FCG |
| Date Received | 2020-03-11 |
| Model Number | NA-201SX-4021 |
| Lot Number | 98V |
| 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 |