MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-28 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[141332682]
The referenced device was not returned to olympus. The cause of the reported event cannot be confirmed at this time. However, if the device is returned at a later date, this report will be supplemented accordingly. As a preventive measure, the needle instruction manual states,? Always have a spare instrument available in case the primary instrument malfunctions.? To prevent breakage, the needle instruction manual also warns, do not use an aspiration needle that has an irregularly bent or deformed needle tube. Do not apply bending force to the handle section. Doing so may damage the instrument and/or endoscope. Do not coil the insertion portion with a diameter of less than 150 mm. Doing so could damage the instrument. Do not try to straighten a bent or deformed needle with your hands because the needle may break. The instruction manual also has directions for pre-procedure visual inspection and functional verification of the needle device.
Patient Sequence No: 1, Text Type: N, H10
[141332683]
Olympus was informed that during the middle of an ebus with biopsy of a lung mass procedure, it was discovered that a piece of the device was stuck in the patient? S tumor during needle aspiration. It is unknown if the needle broke or became detached. The broken piece was retrieved using biopsy forceps. The procedure was completed using the same needle. There was no adverse outcome to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00575 |
| MDR Report Key | 8462111 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-28 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-06-03 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE ASPIRATION NEEDLE |
| Generic Name | VIZISHOT 2 FLEX |
| Product Code | KTI |
| Date Received | 2019-03-28 |
| Model Number | NA-U403SX-4019 |
| Lot Number | FR832348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |