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 2019-05-23 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[146076741]
As part of our investigation, followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event was performed but with no result. It is unknown if the device fragment was retrieved or if the intended procedure was completed. The device was not returned to the service center for evaluation. The cause of the reported event cannot be determined at this time. 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. ? In addition, the instruction manual also has directions for pre-procedure visual inspection and functional verification of the needle device. If the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[146076742]
The service center was informed that during an unspecified procedure, the sheath covering the needle detached and was observed in the patient? S trachea. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00870 |
| MDR Report Key | 8638413 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-23 |
| Date of Report | 2019-09-06 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-05-23 |
| 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 | BRONCHOSCOPE ASPIRATION NEEDLE |
| Product Code | KTI |
| Date Received | 2019-05-23 |
| Returned To Mfg | 2019-06-05 |
| Model Number | NA-U403SX-4019 |
| Lot Number | JF798197 |
| 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 | 2019-05-23 |