MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[129166875]
The device was returned to olympus for evaluation. The evaluation did not duplicate the complaint for the needle tip broken. The needle was found intact. The device was kinked, potentially due to damage during shipment. After the two kinks were straightened out, the needle passed mechanical and functional test. 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.? And? 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
[129166876]
2 of 2. Olympus was informed that during an ebus-tbna procedure, the tip of the needle broke at the first puncture attempt and fell into the patient. The broken off tip was retrieved with another unknown device. There was no reported additional bleeding or patient injury. The procedure was completed with another needle. Before the breakage, there were no reported problems with needle insertion, no needle bending, and no unusual phenomena during the procedure. The equipment had been inspected before use, with no anomalies found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00702 |
| MDR Report Key | 8071980 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-11-14 |
| 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 | 0 |
| Brand Name | SINGLE USE ASPIRATION NEEDLE |
| Generic Name | VIZISHOT 2 FLEX |
| Product Code | KTI |
| Date Received | 2018-11-14 |
| Returned To Mfg | 2018-09-10 |
| Model Number | NA-U403SX-4019 |
| Catalog Number | NA-U403SX-4019 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-14 |