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 |