MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-05-08 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[144852467]
The device was not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Per the instruction manual recommendation to? Always have a spare instrument available in case the primary instrument malfunctions. As a preventive measure against breakage, the instruction manual 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. If using the same instrument several times during an operation, confirm there is no irregularity of the instrument before inserting it into the endoscope. ? Do not try to straighten a bent or deformed needle with your hands because the needle may break.?
Patient Sequence No: 1, Text Type: N, H10
[144852468]
Olympus received a medwatch report that states during an endobronchial ultrasound (ebus) procedure, what appeared to be a soft, flexible metal spring piece was found in the patient? S bronchus. The device fragment was safely retrieved with a forceps. There was no bleeding observed. The intended procedure was completed. This was an inpatient that was already being closely monitored. There was no patient injury reported. Additionally, olympus followed up with the user facility and was informed that the needle was used in the endoscopic field of view and under an ultrasound image. The insertion portion of the needle was coiled with a diameter of less than 150 mm. There were no kinks noted and no resistance was felt on the handle during use. The entire needle was inspected prior to use and no anomalies were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00816 |
| MDR Report Key | 8589552 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-05-08 |
| 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 | 2019-05-08 |
| Model Number | NA-U403SX-4019 |
| Lot Number | FR837912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-08 |