MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-01 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[141343102]
The device was not returned to olympus for evaluation. A picture of the distal end of the device was provided by the user facility. Based on the picture, olympus cannot determine if a piece broke off or detached from the subject device. 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.
Patient Sequence No: 1, Text Type: N, H10
[141343103]
Olympus was informed that near the end of a diagnostic endobronchial ultrasound (ebus) procedure, a piece of metal possibly from the device broke off and went into the patient. The procedure was completed with the same device since the last pass/sample was already obtained when the metal piece was observed on the endoscopic image. The metal piece was retrieved from the patient using grasping forceps without issue. The patient did not require a longer than normal stay or additional procedures. The procedure may have been delayed by a minute or two. The device was inspected prior to use with no abnormalities and it worked well during each pass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00664 |
| MDR Report Key | 8471539 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-01 |
| Date of Report | 2019-07-24 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-07-24 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-04-01 |
| Returned To Mfg | 2019-04-12 |
| Model Number | NA-U403SX-4019 |
| Lot Number | FR837912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-01 |