MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for SINGLE USE ASPIRATION NEEDLE NA-U403SX-4019 manufactured by Gyrus Acmi, Inc..
[108231486]
The device was not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. The procedure was completed using another needle device, 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.? 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. For the attachment of the needle device to the endoscope, the instruction manual states,? Connect this instrument to the biopsy valve in proper direction? Otherwise, this instrument may not function properly, causing bleeding and mucosal membrane damage in patient and/or equipment damage.?
Patient Sequence No: 1, Text Type: N, H10
[108231487]
Olympus was informed that in the middle of an fna biopsy, during an attempt to withdraw the sample, at least 5 inches of the distal length of the needle tube broke from the rest of the device, with the distal tip remaining in the patient? S lymph node. The broken off length was retrieved using a foreign body grabber, and the procedure was completed with another needle device. There was no reported patient injury or other device fragment fallen into the patient. It was reported that prior to the breakage, the needle device kept disconnecting from the endoscope when the slider was operated, and that the needle gradually became bent over the course of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00302 |
| MDR Report Key | 7503428 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-05-10 |
| 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 | 2018-05-10 |
| Returned To Mfg | 2018-07-24 |
| Model Number | NA-U403SX-4019 |
| Catalog Number | NA-U403SX-4019 |
| Lot Number | MK658098 |
| 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 | 2018-05-10 |