MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[109618671]
At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly. Not yet returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[109618672]
The user facility reported that during an ebus procedure a vizishot 2 flex needle was broken inside the patient. The broken part was recovered by the user. The procedure was normally finished by using a second needle. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011050570-2018-00003 |
| MDR Report Key | 7543182 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-05-24 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| 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 | 2018-05-24 |
| Model Number | NA-U403SX-4019 |
| Lot Number | 19G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2018-05-24 |